Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT01320202
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2011-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rd@rockwellmed.com', 'phone': '248-960-9009', 'title': 'Senior Director, Clinical Research & Operations', 'organization': 'Rockwell Medical'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.', 'description': 'The number of subjects included in the safety population = 300, which is 5 patients fewer than the number of patients randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Five subjects withdrew from Stage 2 and 2 subjects withdrew from Stage 3 prior to exposure.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.', 'otherNumAtRisk': 151, 'otherNumAffected': 100, 'seriousNumAtRisk': 151, 'seriousNumAffected': 45}, {'id': 'EG001', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.', 'otherNumAtRisk': 149, 'otherNumAffected': 96, 'seriousNumAtRisk': 149, 'seriousNumAffected': 36}, {'id': 'EG002', 'title': 'Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3).', 'otherNumAtRisk': 205, 'otherNumAffected': 148, 'seriousNumAtRisk': 205, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTERIOVENOUS FISTULA SITE COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 30, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 58, 'numAffected': 25}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTERIOVENOUS FISTULA SITE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTERIOVENOUS FISTULA THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 45, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 52, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 34, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FLUID OVERLOAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 15, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HAEMODIALYSIS-INDUCED SYMPTOM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 199, 'numAffected': 39}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 53, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 33, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 31, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 27, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PROCEDURAL DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PROCEDURAL HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 216, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 174, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 494, 'numAffected': 68}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROMBOSIS IN DEVICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 15, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VASCULAR GRAFT COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 25, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VITAMIN D DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 34, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ACCELERATED HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ACUTE PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ADVERSE DRUG REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANAEMIA OF CHRONIC DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANAEMIA POSTOPERATIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SKIN ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SPONDYLOLISTHESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'STAPHYLOCOCCAL BACTERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'STENT-GRAFT ENDOLEAK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SUDDEN DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SUPRAVENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TOXICITY TO VARIOUS AGENTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UROSEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VASCULAR GRAFT THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means between SFP & PBO', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.6', 'pValueComment': 'LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Hgb measured weekly; up to 48 weeks from the date of randomization', 'description': 'Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean with standard error.', 'unitOfMeasure': 'grams per liter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent-to-treat populations: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measurement obtained.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.'}], 'classes': [{'title': 'mean pre-dialysis serum iron', 'categories': [{'measurements': [{'value': '12.1', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '3.04', 'groupId': 'OG001'}]}]}, {'title': 'mean post-dialysis serum iron', 'categories': [{'measurements': [{'value': '29.6', 'spread': '8.64', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '3.91', 'groupId': 'OG001'}]}]}, {'title': 'serum iron change from pre- to post-dialysis', 'categories': [{'measurements': [{'value': '17.5', 'spread': '8.70', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '3.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.', 'unitOfMeasure': 'micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent-to-treat population: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.'}], 'classes': [{'title': 'mean pre-dialysis TSAT(transferrin)', 'categories': [{'measurements': [{'value': '24.9', 'spread': '6.86', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '5.97', 'groupId': 'OG001'}]}]}, {'title': 'mean post-dialysis TSAT(transferrin)', 'categories': [{'measurements': [{'value': '57.9', 'spread': '15.94', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '7.80', 'groupId': 'OG001'}]}]}, {'title': 'pre- to post-dialysis change in TSAT', 'categories': [{'measurements': [{'value': '32.7', 'spread': '15.83', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '6.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent-to treat: all randomized subjects who had at least one dose of study drug and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.'}], 'classes': [{'title': 'mean pre-dialysis UIBC', 'categories': [{'measurements': [{'value': '31.49', 'spread': '6.797', 'groupId': 'OG000'}, {'value': '32.27', 'spread': '6.580', 'groupId': 'OG001'}]}]}, {'title': 'mean post-dialysis UIBC', 'categories': [{'measurements': [{'value': '19.48', 'spread': '7.911', 'groupId': 'OG000'}, {'value': '34.51', 'spread': '7.208', 'groupId': 'OG001'}]}]}, {'title': 'pre- to post-dialysis change in UIBC', 'categories': [{'measurements': [{'value': '-11.86', 'spread': '6.604', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '3.253', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.', 'unitOfMeasure': 'micromole per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 weeks from the date of randomization', 'description': 'The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT): all patients randomized are included.'}, {'type': 'SECONDARY', 'title': 'Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 weeks from the date of randomization', 'description': 'The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.', 'unitOfMeasure': 'units of red blood cells or whole blood', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT): all patients randomized are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}], 'classes': [{'title': 'CHr: % of change from baseline', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '3.800', 'groupId': 'OG000'}, {'value': '-2.73', 'spread': '4.289', 'groupId': 'OG001'}]}]}, {'title': 'Ferritin: % of change from baseline', 'categories': [{'measurements': [{'value': '-14.8', 'spread': '27.68', 'groupId': 'OG000'}, {'value': '-28.5', 'spread': '34.35', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dialysis UIBC: % of change from baseline', 'categories': [{'measurements': [{'value': '8.36', 'spread': '53.186', 'groupId': 'OG000'}, {'value': '7.62', 'spread': '14.818', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dialysis serum iron: % of change from baseline', 'categories': [{'measurements': [{'value': '4.644', 'spread': '53.1728', 'groupId': 'OG000'}, {'value': '-4.628', 'spread': '29.0307', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dialysis transferrin: % change from baseline', 'categories': [{'measurements': [{'value': '1.718', 'spread': '8.5133', 'groupId': 'OG000'}, {'value': '2.633', 'spread': '9.7691', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dialysis TIBC: % of change from baseline', 'categories': [{'measurements': [{'value': '1.80', 'spread': '9.255', 'groupId': 'OG000'}, {'value': '2.88', 'spread': '10.253', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dialysis TSAT: % of change from baseline', 'categories': [{'measurements': [{'value': '1.8', 'spread': '44.99', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '26.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and Total Iron-Binding Capacity (TIBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}], 'classes': [{'title': 'Baseline UIBC', 'categories': [{'measurements': [{'value': '30.91', 'spread': '6.784', 'groupId': 'OG000'}, {'value': '30.77', 'spread': '6.452', 'groupId': 'OG001'}]}]}, {'title': 'EoT UIBC', 'categories': [{'measurements': [{'value': '32.76', 'spread': '13.734', 'groupId': 'OG000'}, {'value': '33.03', 'spread': '7.527', 'groupId': 'OG001'}]}]}, {'title': 'UIBC: Change from Baseline to EoT', 'categories': [{'measurements': [{'value': '1.93', 'spread': '13.265', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '4.447', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Serum Iron', 'categories': [{'measurements': [{'value': '11.976', 'spread': '3.9192', 'groupId': 'OG000'}, {'value': '11.443', 'spread': '3.9198', 'groupId': 'OG001'}]}]}, {'title': 'EoT Serum Iron', 'categories': [{'measurements': [{'value': '11.911', 'spread': '4.5412', 'groupId': 'OG000'}, {'value': '10.389', 'spread': '3.4941', 'groupId': 'OG001'}]}]}, {'title': 'Serum Iron: Change from Baseline to EoT', 'categories': [{'measurements': [{'value': '-0.196', 'spread': '4.7462', 'groupId': 'OG000'}, {'value': '-1.051', 'spread': '3.6562', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TIBC', 'categories': [{'measurements': [{'value': '42.88', 'spread': '7.458', 'groupId': 'OG000'}, {'value': '42.22', 'spread': '7.380', 'groupId': 'OG001'}]}]}, {'title': 'EoT TIBC', 'categories': [{'measurements': [{'value': '43.59', 'spread': '8.140', 'groupId': 'OG000'}, {'value': '43.40', 'spread': '7.964', 'groupId': 'OG001'}]}]}, {'title': 'TIBC: Change from Baseline to EoT', 'categories': [{'measurements': [{'value': '0.65', 'spread': '4.051', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '4.296', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.', 'unitOfMeasure': 'micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}], 'classes': [{'title': 'Baseline CHr', 'categories': [{'measurements': [{'value': '32.37', 'spread': '1.985', 'groupId': 'OG000'}, {'value': '32.57', 'spread': '1.953', 'groupId': 'OG001'}]}]}, {'title': 'EoT CHr', 'categories': [{'measurements': [{'value': '32.12', 'spread': '2.016', 'groupId': 'OG000'}, {'value': '31.64', 'spread': '2.019', 'groupId': 'OG001'}]}]}, {'title': 'CHr: Change from Baseline to EoT', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '1.203', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '1.413', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.', 'unitOfMeasure': 'picograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End-of-Treatment (EoT) in Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}], 'classes': [{'title': 'Baseline Ferritin', 'categories': [{'measurements': [{'value': '509.6', 'spread': '194.16', 'groupId': 'OG000'}, {'value': '511.3', 'spread': '209.68', 'groupId': 'OG001'}]}]}, {'title': 'EoT Ferritin', 'categories': [{'measurements': [{'value': '440.7', 'spread': '216.41', 'groupId': 'OG000'}, {'value': '366.9', 'spread': '224.01', 'groupId': 'OG001'}]}]}, {'title': 'Ferritin: Change from Baseline to EoT', 'categories': [{'measurements': [{'value': '-72.3', 'spread': '133.40', 'groupId': 'OG000'}, {'value': '-143.1', 'spread': '188.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin will be quantified.', 'unitOfMeasure': 'micrograms per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}], 'classes': [{'title': 'Baseline Pre-Dialysis Transferrin', 'categories': [{'measurements': [{'value': '1.928', 'spread': '0.3427', 'groupId': 'OG000'}, {'value': '1.908', 'spread': '0.3475', 'groupId': 'OG001'}]}]}, {'title': 'EoT Pre-Dialysis Transferrin', 'categories': [{'measurements': [{'value': '1.958', 'spread': '0.3767', 'groupId': 'OG000'}, {'value': '1.957', 'spread': '0.3731', 'groupId': 'OG001'}]}]}, {'title': 'Pre-Dialysis Ferritin: Change from Baseline to EoT', 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.1695', 'groupId': 'OG000'}, {'value': '0.044', 'spread': '0.1883', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin will be quantified.', 'unitOfMeasure': 'grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}], 'classes': [{'title': 'Baseline Pre-Dialysis TSAT', 'categories': [{'measurements': [{'value': '28.1', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '7.79', 'groupId': 'OG001'}]}]}, {'title': 'EoT Pre-Dialysis TSAT', 'categories': [{'measurements': [{'value': '27.3', 'spread': '8.52', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '7.44', 'groupId': 'OG001'}]}]}, {'title': 'Pre-Dialysis TSAT: Change from Baseline to EoT', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '9.16', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '7.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) will be quantified.', 'unitOfMeasure': 'percentage of saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Variability of Hemoglobin Concentration: Temporal Trend', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.060', 'spread': '0.298', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.235', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hgb measured weekly; up to 48 weeks from the date of randomization', 'description': 'The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.', 'unitOfMeasure': 'grams per liter per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.'}, {'type': 'SECONDARY', 'title': 'Variability of Hemoglobin Concentration: Residual Standard Deviation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.104', 'spread': '2.220', 'groupId': 'OG000'}, {'value': '4.588', 'spread': '1.949', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hgb measured weekly; up to 48 weeks from the date of randomization', 'description': 'The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.', 'unitOfMeasure': 'grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2 Placebo (Standard Dialysate)', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2.'}], 'classes': [{'title': 'mean baseline hemoglobin', 'categories': [{'measurements': [{'value': '109.6', 'spread': '5.91', 'groupId': 'OG000'}, {'value': '109.0', 'spread': '6.36', 'groupId': 'OG001'}]}]}, {'title': 'mean end-of-treatment hemoglobin', 'categories': [{'measurements': [{'value': '109.1', 'spread': '12.53', 'groupId': 'OG000'}, {'value': '105.2', 'spread': '13.65', 'groupId': 'OG001'}]}]}, {'title': 'mean change in Hemoglobin at end-of-treatment', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '11.67', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '12.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hgb measured weekly; up to 48 weeks from the date of randomization', 'description': 'Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).', 'unitOfMeasure': 'grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent-to-treat: all randomized patients who received at least one dose of study drug and had at least one post-dose hemoglobin measured.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.'}, {'id': 'FG001', 'title': 'Standard Dialysate', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'Comp 48 Wks in St 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Comp St 2 Due to ESA/IV Iron Needs', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'Enrolled in St 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'Completed St 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'non-protocol change to ESA or IV iron', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'kidney transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'blood transfusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'moved/changed dialysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'sponsor request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'regained renal function', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Soluble Ferric Pyrophosphate (SFP) in Dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nSoluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.'}, {'id': 'BG001', 'title': 'Standard Dialysate', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.\n\nStandard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 18 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '12.56', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '13.01', 'groupId': 'BG001'}, {'value': '58.3', 'spread': '12.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'post-dialysis body weight', 'classes': [{'categories': [{'measurements': [{'value': '84.08', 'spread': '23.264', 'groupId': 'BG000'}, {'value': '83.15', 'spread': '22.166', 'groupId': 'BG001'}, {'value': '83.61', 'spread': '22.685', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'height', 'classes': [{'categories': [{'measurements': [{'value': '168.48', 'spread': '10.197', 'groupId': 'BG000'}, {'value': '169.17', 'spread': '9.350', 'groupId': 'BG001'}, {'value': '168.82', 'spread': '9.771', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat population: all randomized subjects, regardless of whether they received any investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2011-03-20', 'resultsFirstSubmitDate': '2015-03-20', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-22', 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean', 'timeFrame': 'Hgb measured weekly; up to 48 weeks from the date of randomization', 'description': 'Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean with standard error.'}, {'measure': 'Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb', 'timeFrame': 'Hgb measured weekly; up to 48 weeks from the date of randomization', 'description': 'Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.'}, {'measure': 'Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis.', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.'}, {'measure': 'Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis.', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.'}, {'measure': 'Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion', 'timeFrame': 'up to 48 weeks from the date of randomization', 'description': 'The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.'}, {'measure': 'Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused', 'timeFrame': 'up to 48 weeks from the date of randomization', 'description': 'The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.'}, {'measure': 'Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).'}, {'measure': 'Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and Total Iron-Binding Capacity (TIBC)', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.'}, {'measure': 'Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr)', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.'}, {'measure': 'Change From Baseline to End-of-Treatment (EoT) in Ferritin', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin will be quantified.'}, {'measure': 'Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin will be quantified.'}, {'measure': 'Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)', 'timeFrame': 'Up to 48 weeks from the date of randomization', 'description': 'The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) will be quantified.'}, {'measure': 'Variability of Hemoglobin Concentration: Temporal Trend', 'timeFrame': 'Hgb measured weekly; up to 48 weeks from the date of randomization', 'description': 'The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.'}, {'measure': 'Variability of Hemoglobin Concentration: Residual Standard Deviation', 'timeFrame': 'Hgb measured weekly; up to 48 weeks from the date of randomization', 'description': 'The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['End Stage Renal Disease', 'Hemodialysis', 'SFP', 'Hemodialysis-dependent chronic renal failure'], 'conditions': ['Renal Failure Chronic Requiring Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '26175145', 'type': 'DERIVED', 'citation': 'Fishbane SN, Singh AK, Cournoyer SH, Jindal KK, Fanti P, Guss CD, Lin VH, Pratt RD, Gupta A. Ferric pyrophosphate citrate (Triferic) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients. Nephrol Dial Transplant. 2015 Dec;30(12):2019-26. doi: 10.1093/ndt/gfv277. Epub 2015 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).', 'detailedDescription': 'Screening: 2-3 weeks prior to enrollment in Stage 1.\n\nStage 1 (Run-In): 1-4 weeks depending on qualification for Stage 2.\n\nStage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.\n\nStage 3 (Open-Label Treatment): The duration of Stage 2 plus Stage 3 is intended to be 18 months regardless of treatment assignment in Stage 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Stage 1:\n\nMain Inclusion Criteria:\n\n* Adult subject ≥ 18 years of age undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD) for at least 4 months, and expected to remain on hemodialysis three to four times weekly and be able to complete the duration of the study.\n* Received IV iron therapy between 6 months and 2 weeks prior to enrollment in order to replace iron losses resulting from hemodialysis procedure.\n* Mean Screening Hgb ≥ 9.5 to ≤ 11.5 grams per deciliter (g/dL).\n* Mean Screening Transferrin Saturation (TSAT) ≥ 15% to ≤ 40%.\n* Mean Screening serum ferritin ≥ 200 to ≤ 800 micrograms per liter (µg/L).\n* If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 Units (U)/week, darbepoetin dose ≤ 200 micrograms (µg)/week, or CERA dose ≤ 400 micrograms (µg)/month during the four weeks prior to enrollment.\n\nMain Exclusion Criteria:\n\n* Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.)\n* Vascular access for dialysis with femoral catheter or non-tunneled catheter.\n* Received a total of \\> 800 milligrams (mg) IV iron during the 8 weeks prior to enrollment\n* If being administered an ESA, route of administration change or ESA dose change \\> 35% (i.e., \\[max - min dose\\]/max dose \\> 0.35) over the 2 weeks prior to screening.\n* Serum albumin \\< 3.0 grams per deciliter (g/dL) any time over the 8 weeks prior to enrollment.\n* Red Blood Cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment.\n\nStage 2:\n\nMain Inclusion Criteria:\n\n* Patient currently enrolled in the Stage 1 run-in period of study.\n* Undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD), and expected to remain on hemodialysis three to four times weekly and be able to complete duration of the study.\n* Mean Hgb ≥ 9.5 to ≤ 11.5 g/dL over the three most recent consecutive every-week measurements prior to randomization.\n* Stable Hgb defined as ≤ 1.0 g/dL difference between the maximum and minimum Hgb values over the 3 weeks immediately prior to randomization.\n* Mean TSAT ≥ 15% to ≤ 40% over the two most recent consecutive every-other-week measurements prior to randomization.\n* Mean serum ferritin ≥ 200 to ≤ 800 µg/L over the two most recent consecutive every-other-week measurements prior to randomization.\n* If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 U/week, darbepoetin dose ≤ 200 µg/week, or CERA dose ≤ 400 µg/month during the four weeks prior to randomization.\n\nMain Exclusion Criteria:\n\n* Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.)\n* Vascular access for dialysis with femoral catheter or non-tunneled catheter.\n* Received any amount of IV iron during the 4 weeks prior to randomization.\n* If being administered an (Erythropoietin Stimulating Agent) ESA, change in dose over the 6 weeks immediately prior to randomization.\n* Serum albumin \\< 3.0 g/dL any time over the 8 weeks prior to randomization.\n* RBC or whole blood transfusion during Stage 1.\n\nStage 3:\n\nMain Inclusion Criteria:\n\n* Patient randomized in Stage 2 who has completed the full duration of Stage 2 and less than 4 weeks have elapsed since completion of Stage 2, OR\n* Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for protocol-defined Protocol-Mandated Change in Anemia Management and less than 4 weeks have elapsed since withdrawal from Stage 2, OR\n* Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for Hgb \\>11.5 g/dL over ≥ 1 week confirmed by ≥ 2 consecutive measurements AND an associated increase in Hgb by ≥ 1 g/dL over 4 weeks.\n\nMain Exclusion Criteria:\n\n* Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for any reason other than as noted in inclusion criteria above.'}, 'identificationModule': {'nctId': 'NCT01320202', 'acronym': 'CRUISE 1', 'briefTitle': 'Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rockwell Medical Technologies, Inc.'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents (CRUISE 1) Study', 'orgStudyIdInfo': {'id': 'RMTI-SFP-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Soluble Ferric Pyrophosphate (SFP) in dialysate', 'description': '11 micrograms (µg) of iron / deciliter (dL) of dialysate.', 'interventionNames': ['Drug: Soluble Ferric Pyrophosphate (SFP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Dialysate', 'description': '0 micrograms (µg) of iron / deciliter (dL) of dialysate.', 'interventionNames': ['Device: Standard dialysate']}], 'interventions': [{'name': 'Soluble Ferric Pyrophosphate (SFP)', 'type': 'DRUG', 'description': 'Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.', 'armGroupLabels': ['Soluble Ferric Pyrophosphate (SFP) in dialysate']}, {'name': 'Standard dialysate', 'type': 'DEVICE', 'description': 'Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.', 'armGroupLabels': ['Standard Dialysate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93308', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 35.37329, 'lon': 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34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '91764', 'city': 'Ontario', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.06334, 'lon': -117.65089}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '92505', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '91773', 'city': 'San Dimas', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.10668, 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25.77427, 'lon': -80.19366}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60617', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46360', 'city': 'Michigan City', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.70754, 'lon': -86.89503}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '11385', 'city': 'Ridgewood', 'state': 'New York', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.7001, 'lon': -73.90569}}, {'zip': '11422', 'city': 'Rosedale', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.66205, 'lon': -73.73541}}, {'zip': '10704', 'city': 'Yonkers', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.9304, 'lon': -73.89789}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27105', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45206', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43613', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '29150', 'city': 'Sumter', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.92044, 'lon': -80.34147}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '76164', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22030', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '53211', 'city': 'Shorewood', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.08918, 'lon': -87.88758}}, {'zip': '00725', 'city': 'Caguas', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}, {'zip': '00987', 'city': 'Carolina', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.38078, 'lon': -65.95739}}], 'overallOfficials': [{'name': 'Ray Pratt, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rockwell Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rockwell Medical Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}