Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 4:20 AM
Study NCT ID:
NCT02285920
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2014-10-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013148', 'term': 'Spironolactone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ldember@pennmedicine.upenn.edu', 'phone': '215-573-5264', 'title': 'Laura M. Dember, MD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.', 'description': 'Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form.\n\nAdverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 45, 'seriousNumAtRisk': 51, 'deathsNumAffected': 2, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 24, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 25, 'seriousNumAtRisk': 26, 'deathsNumAffected': 2, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 23, 'seriousNumAtRisk': 25, 'deathsNumAffected': 1, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain, nausea, diarrhea, constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 21, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain, peripheral edema, malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis, diverticulitis, cystitis, cellulitis, naspharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall, rib fracture, vascular graft complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin biopsy, liver biopsy, low hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkalemia, hyperphosphatemia, hypercalcemia, gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 70, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 26, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 34, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 39, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia, arthritis, osteoarthritis, tendonitis, neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness, headache, migraine, tremor, syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysuria, hematuria, incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast tenderness, enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COPD, pleural effusion, asthma, cough, dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritis, rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'AV fistula, thrombectomy, catheter placement, stent placment, amputation, vascular operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 90, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 30, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 46, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 75, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute MI, atrial fibrillation, bradycardia, palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain, diarrhea, GI hemorrhage, nausea, vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia, chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hemobilia, hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacteremia, influenza, osteomyelitis, pneumonia. sepsis, skin graft infection, UTI, viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'AVfistula site hemorrhage, vascular access complications, fall, laceration, rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac catheterisation, fistulogram, pleural biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkalemia, hypocalcemia, fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 14, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia, back pain, neck pain, extremity pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric cancer, renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Balance disorder, dementia, headache, paralysis, syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety, depression, mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder mass, hematuria, urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma, COPD, cough , dyspnea, pleural effusion, stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blister, erythema, pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angioplasty, catheter placement, toe amputation, renal transplant, thrombectomy, nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension, hypotension, thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety - Number of Participants With Serum Potassium >6.5 mEq/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 40 weeks', 'description': 'The number of participants who had serum potassium \\>6.5 mEq/L was assessed by treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety - Participants With Serious Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 40 weeks', 'description': 'The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Study Drug Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 36 weeks', 'description': 'Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Efficacy - Change in Mitral Annular E' Velocity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'title': "Baseline MA E'", 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '7.0', 'spread': '1.9', 'groupId': 'OG003'}]}]}, {'title': "36 Week MA E'", 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '7.3', 'spread': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Change between baseline - 36 weeks', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 36 weeks', 'description': "Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy.", 'unitOfMeasure': 'cm/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.'}, {'type': 'PRIMARY', 'title': 'Feasibility of Conducting a Full-scale Mortality-powered Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'categories': [{'title': 'Kidney transplantation', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Change to peritoneal dialysis', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Transfer to non-participating facility', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Dialysis discontinued', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Death', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Study completed', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 40 weeks', 'description': 'An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety - Number of Participants With Serious Hyperkalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 40 weeks', 'description': 'Number of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety - Hyperkalemia Requiring Adjustment in Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 40 weeks', 'description': 'Hyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety - Inter- or Intra-dialytic Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'categories': [{'title': 'Inter-dialytic hypotension only', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Intra-dialytic hypotension only', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}, {'title': 'Inter- & intra-dialytic hypotension', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'No inter- or intra-dialytic hypotension', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 40 weeks', 'description': 'Inter- or intra-dialytic hypotension defined as:\n\n1. Inter-dialytic: systolic blood pressure \\<90 mm Hg or inter-dialytic hypotension requiring adjustment in anti-hypertensive medications or treatment in a hospital or emergency room.\n2. Intra-dialytic: systolic blood pressure \\<80 mm Hg during ≥3 dialysis sessions per 30-day period or treatment for either hypotension or symptoms of hypotension during ≥3 dialysis sessions per 30-day period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety - Cardiovascular Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 40 weeks', 'description': 'Number of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'title': 'LVEF Baseline', 'categories': [{'measurements': [{'value': '68.9', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '65.9', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '66.0', 'spread': '11.4', 'groupId': 'OG002'}, {'value': '68.2', 'spread': '5.8', 'groupId': 'OG003'}]}]}, {'title': 'LVEF 36-Week', 'categories': [{'measurements': [{'value': '70.7', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '66.9', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '65.3', 'spread': '13.9', 'groupId': 'OG002'}, {'value': '69.5', 'spread': '6.3', 'groupId': 'OG003'}]}]}, {'title': 'LVEF Change', 'categories': [{'measurements': [{'value': '1.8', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '7.3', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '3.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 36 weeks', 'description': 'Secondary outcome measures include other echocardiographic markers of systolic and diastolic function\n\n• Change in left ventricular ejection fraction between Baseline and 36 weeks', 'unitOfMeasure': 'percent ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.'}, {'type': 'SECONDARY', 'title': 'Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'title': 'LVMI Baseline', 'categories': [{'measurements': [{'value': '105.2', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '115.5', 'spread': '26.7', 'groupId': 'OG001'}, {'value': '116.4', 'spread': '26.9', 'groupId': 'OG002'}, {'value': '106.3', 'spread': '29.2', 'groupId': 'OG003'}]}]}, {'title': 'LVMI 36-Week', 'categories': [{'measurements': [{'value': '94.8', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '104.6', 'spread': '27.0', 'groupId': 'OG001'}, {'value': '109.1', 'spread': '30.5', 'groupId': 'OG002'}, {'value': '96.5', 'spread': '25.7', 'groupId': 'OG003'}]}]}, {'title': 'LVMI Change', 'categories': [{'measurements': [{'value': '-10.4', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '-10.9', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '-7.3', 'spread': '21.0', 'groupId': 'OG002'}, {'value': '-9.8', 'spread': '9.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 36 weeks', 'description': 'Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,\n\n• Change in left ventricular mass index (LVMI) between baseline and 36 weeks', 'unitOfMeasure': 'g/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.'}, {'type': 'SECONDARY', 'title': "Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E')", 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'title': "E/E' Baseline", 'categories': [{'measurements': [{'value': '10.7', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '5.0', 'groupId': 'OG002'}, {'value': '12.5', 'spread': '5.6', 'groupId': 'OG003'}]}]}, {'title': "E/E' 36-Week", 'categories': [{'measurements': [{'value': '11.5', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '80.', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '11.9', 'spread': '5.5', 'groupId': 'OG003'}]}]}, {'title': "E/E' Change", 'categories': [{'measurements': [{'value': '0.9', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '4.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 36 weeks', 'description': "Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,\n\n• E/E' is the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')", 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.'}, {'type': 'SECONDARY', 'title': 'Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'title': 'LVGLS Baseline', 'categories': [{'measurements': [{'value': '-17.2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '-16.7', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '-17.2', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '-17.4', 'spread': '3.0', 'groupId': 'OG003'}]}]}, {'title': 'LVGLS 36-week', 'categories': [{'measurements': [{'value': '-18.1', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '-17.0', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '-17.0', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '-18.2', 'spread': '3.0', 'groupId': 'OG003'}]}]}, {'title': 'LVGLS Change', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '2.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 36 weeks', 'description': 'Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,\n\n• Change in myocardial strain and strain rate between baseline and 36 weeks', 'unitOfMeasure': '% of myocardial shortening', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.'}, {'type': 'SECONDARY', 'title': 'Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'OG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 40 Weeks', 'description': 'The number of participants who had serum potassium \\>6.5 mEq/L or serious hyperkalemia was assessed by treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'FG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'FG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'FG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Kidney transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Change to peritoneal dialysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Transfer to non-participating unit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Dialysis discontinuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'BG001', 'title': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'BG002', 'title': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'BG003', 'title': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.\n\nSpironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '13.5', 'groupId': 'BG002'}, {'value': '55.5', 'spread': '9.8', 'groupId': 'BG003'}, {'value': '55.5', 'spread': '12.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants were enrolled from dialysis units affiliated with four U.S. academic medical centers. The Institutional Review Boards affiliated with the clinical centers and with the data coordinating center approved the protocol and all participants provided informed consent.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-09', 'size': 1022502, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-19T14:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-16', 'studyFirstSubmitDate': '2014-10-13', 'resultsFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-16', 'studyFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Number of Participants With Serum Potassium >6.5 mEq/L', 'timeFrame': '0 - 40 weeks', 'description': 'The number of participants who had serum potassium \\>6.5 mEq/L was assessed by treatment arm.'}, {'measure': 'Safety - Participants With Serious Hypotension', 'timeFrame': '0 - 40 weeks', 'description': 'The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection).'}, {'measure': 'Study Drug Tolerability', 'timeFrame': '0 - 36 weeks', 'description': 'Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction.'}, {'measure': "Efficacy - Change in Mitral Annular E' Velocity", 'timeFrame': 'Baseline to 36 weeks', 'description': "Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy."}, {'measure': 'Feasibility of Conducting a Full-scale Mortality-powered Trial', 'timeFrame': '0 - 40 weeks', 'description': 'An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates.'}], 'secondaryOutcomes': [{'measure': 'Safety - Number of Participants With Serious Hyperkalemia', 'timeFrame': '0 - 40 weeks', 'description': 'Number of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy'}, {'measure': 'Safety - Hyperkalemia Requiring Adjustment in Treatment', 'timeFrame': '0 - 40 weeks', 'description': 'Hyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication'}, {'measure': 'Safety - Inter- or Intra-dialytic Hypotension', 'timeFrame': '0 - 40 weeks', 'description': 'Inter- or intra-dialytic hypotension defined as:\n\n1. Inter-dialytic: systolic blood pressure \\<90 mm Hg or inter-dialytic hypotension requiring adjustment in anti-hypertensive medications or treatment in a hospital or emergency room.\n2. Intra-dialytic: systolic blood pressure \\<80 mm Hg during ≥3 dialysis sessions per 30-day period or treatment for either hypotension or symptoms of hypotension during ≥3 dialysis sessions per 30-day period'}, {'measure': 'Safety - Cardiovascular Death', 'timeFrame': '0 - 40 weeks', 'description': 'Number of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease'}, {'measure': 'Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'Baseline - 36 weeks', 'description': 'Secondary outcome measures include other echocardiographic markers of systolic and diastolic function\n\n• Change in left ventricular ejection fraction between Baseline and 36 weeks'}, {'measure': 'Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI)', 'timeFrame': 'Baseline - 36 weeks', 'description': 'Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,\n\n• Change in left ventricular mass index (LVMI) between baseline and 36 weeks'}, {'measure': "Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E')", 'timeFrame': 'Baseline - 36 weeks', 'description': "Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,\n\n• E/E' is the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')"}, {'measure': 'Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS)', 'timeFrame': 'Baseline - 36 weeks', 'description': 'Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,\n\n• Change in myocardial strain and strain rate between baseline and 36 weeks'}, {'measure': 'Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia', 'timeFrame': '0 - 40 Weeks', 'description': 'The number of participants who had serum potassium \\>6.5 mEq/L or serious hyperkalemia was assessed by treatment arm.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hemodialysis', 'spironolactone', 'cardiac fibrosis', 'diastolic function'], 'conditions': ['End-Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '33586138', 'type': 'DERIVED', 'citation': 'Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.', 'detailedDescription': "The primary objective of this study is to characterize the safety and tolerability of multiple doses of chronic SPL therapy compared with placebo in maintenance hemodialysis patients and to assess the feasibility of conducting a full-scale, mortality-powered trial of SPL. The effects of SPL compared with placebo on multiple cardiovascular efficacy parameters will also be analyzed. The primary efficacy parameter will be the change in the E' measurement on tissue Doppler echocardiography (TDI) as an index of diastolic function and a surrogate for myocardial fibrosis. Secondary cardiac parameters of interest that will be studied in the overall population or in sub-studies include heart rate variability, circulating markers of fibrosis, and coronary flow reserve (CFR) as an index of microvascular function. These parameters are designed to broaden insight into the potential effects of SPL on cardiac structure and function in individuals with dialysis-dependent ESRD and to assess the feasibility of conducting a full-scale, mortality-powered trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Maintenance hemodialysis therapy for end-stage renal disease\n2. Age 18-85 years\n3. ≥3 calendar months since dialysis initiation. Note if a patient has been on dialysis for ≥3 but less than 6 calendar months, there must be no hospitalizations during the 6 weeks prior to screening, and no change in estimated dry weight (EDW) within 2 weeks of the screening date.\n4. For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug.\n5. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Serum potassium ≥6.5 mEq/L within the 3 months prior to screening\n2. Serum potassium level ≥6.0 mEq/L within 2 weeks prior to the baseline visit. If a potassium value is not available through routine clinical care during this 2-week period a potassium measurement will be performed as a research test.\n3. Unscheduled dialysis for hyperkalemia within the 3 months prior to screening\n4. Pre-dialysis systolic blood pressure \\<100 mm Hg within 2 weeks prior to screening or at the baseline visit\n5. 2 or more dialysis sessions within the month prior to screening with either 2 intra-dialytic measurements of systolic blood pressure \\<80 mm Hg or muscle cramping, light-headedness, nausea or hypotension requiring infusion of saline or other intervention directed at hypotension\n6. Current dual use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)\n7. Current use of digoxin\n8. Current use of spironolactone or eplerenone\n9. Allergy to spironolactone\n10. Inability to maintain dialysis machine blood flow ≥300 mL/min during any of the most recent 3 dialysis sessions prior to the screening visit as an indicator of vascular access dysfunction\n11. Mitral valve repair or replacement\n12. Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging\n13. Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months\n14. Expected survival \\<9 months\n15. Pregnancy, anticipated pregnancy, or breastfeeding\n16. Incarceration\n17. Participation in another intervention study'}, 'identificationModule': {'nctId': 'NCT02285920', 'acronym': 'SPin-D', 'briefTitle': 'Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End-Stage Renal Disease (ESRD) (SPin-D) Trial', 'orgStudyIdInfo': {'id': '821193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spironolactone 12.5 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.', 'interventionNames': ['Drug: Spironolactone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spironolactone 25 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.', 'interventionNames': ['Drug: Spironolactone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spironolactone 50 mg', 'description': 'Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.', 'interventionNames': ['Drug: Spironolactone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be treated with placebo for 36 weeks.', 'interventionNames': ['Drug: Spironolactone']}], 'interventions': [{'name': 'Spironolactone', 'type': 'DRUG', 'description': 'The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.', 'armGroupLabels': ['Placebo', 'Spironolactone 12.5 mg', 'Spironolactone 25 mg', 'Spironolactone 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'The George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kidney Research Institute, University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Laura M Dember, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'George Washington University', 'class': 'OTHER'}, {'name': 'Vanderbilt University', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}