Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:15 PM
Study NCT ID:
NCT04736628
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2021-02-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '"All-Cause Mortality" "Serious Adverse Events" and "Other Adverse Events": From first avenciguat intake until last avenciguat intake or patient\'s trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.', 'description': 'Treated Set (TS): this patient set included all patients who received at least 1 dose of trial medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Avenciguat 1 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Weeks 1 to 20 (included).\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 17, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Avenciguat 2 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg of avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 20 of treatment.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 19, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Avenciguat 3 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg avenciguat (one film-coated tablet of 3 mg) TID occurred from Week 5 until Week 20.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 26, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants. Participants were administered film-coated tablets of placebo matching avenciguat 1mg, 2mg or 3mg 3 times a day (TID) during 20 weeks of treatment.\n\nPlacebo matching avenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 21, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Haemorrhagic diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Appendicitis noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Incision site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Avenciguat 1 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Weeks 1 to 20 (included).\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Avenciguat 2 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg of avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 20 of treatment.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG002', 'title': 'Avenciguat 3 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg avenciguat (one film-coated tablet of 3 mg) TID occurred from Week 5 until Week 20.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants. Participants were administered film-coated tablets of placebo matching avenciguat 1mg, 2mg or 3mg 3 times a day (TID) during 20 weeks of treatment.\n\nPlacebo matching avenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.210', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-0.190', 'spread': '0.068', 'groupId': 'OG001'}, {'value': '-0.217', 'spread': '0.068', 'groupId': 'OG002'}, {'value': '0.018', 'spread': '0.068', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0179', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.228', 'ciLowerLimit': '-0.417', 'ciUpperLimit': '-0.040', 'estimateComment': 'Least Squares Mean of "Avenciguat 1 mg TID" - Least Squares Mean of "Placebo".', 'groupDescription': 'Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.', 'statisticalMethod': 'Mixed-effect Model repeat Measurement', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0307', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.209', 'ciLowerLimit': '-0.398', 'ciUpperLimit': '-0.020', 'estimateComment': 'Least Squares Mean of "Avenciguat 2 mg TID" - Least Squares Mean of "Placebo".', 'groupDescription': 'Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.', 'statisticalMethod': 'Mixed-effect Model repeat Measurement', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0151', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.235', 'ciLowerLimit': '-0.425', 'ciUpperLimit': '-0.046', 'estimateComment': 'Least Squares Mean of "Avenciguat 3 mg TID" - Least Squares Mean of "Placebo".', 'groupDescription': 'Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.', 'statisticalMethod': 'Mixed-effect Model repeat Measurement', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0053', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).\n\nThe total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg).', 'statisticalMethod': 'MCP-Mod E-max model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model assumption: 80% of the maximum effect is achieved at 6 mg.', 'nonInferiorityComment': 'MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.'}, {'pValue': '0.0102', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).\n\nThe total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg).', 'statisticalMethod': 'MCP-Mod quadratic model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.', 'nonInferiorityComment': 'MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.'}, {'pValue': '0.0230', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).\n\nThe total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg).', 'statisticalMethod': 'MCP-Mod linear model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model assumption: no assumption is needed.', 'nonInferiorityComment': 'MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.'}, {'pValue': '0.0292', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).\n\nThe total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg).', 'statisticalMethod': 'MCP-Mod Sigmoid Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.', 'nonInferiorityComment': 'MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.'}, {'pValue': '0.0468', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).\n\nThe total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg).', 'statisticalMethod': 'MCP-Mod Exponential model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Model assumption: 20% of the maximum effect is achieved at 3 mg.', 'nonInferiorityComment': 'MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2, Week -1, Week 0 pre-dose) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.', 'description': 'Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment is reported.\n\nLeast Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12, and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.\n\nLog transformed UACR at Week 20 was log of (average of all available scheduled measurements between week 18 and week 20).\n\nThe data in the Outcome Measure Data Table represent the Least Squares Mean (Standard error) at Week 20.', 'unitOfMeasure': 'log (mg/g)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all patients who had at least one baseline measurement of UACR in Week -2, -1, or 0 and at least 1 post-baseline measurement after Week 6.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Avenciguat 1 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Weeks 1 to 20 (included).\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Avenciguat 2 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg of avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 20 of treatment.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG002', 'title': 'Avenciguat 3 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg avenciguat (one film-coated tablet of 3 mg) TID occurred from Week 5 until Week 20.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants. Participants were administered film-coated tablets of placebo matching avenciguat 1mg, 2mg or 3mg 3 times a day (TID) during 20 weeks of treatment.\n\nPlacebo matching avenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.190', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-0.180', 'spread': '0.073', 'groupId': 'OG001'}, {'value': '-0.161', 'spread': '0.071', 'groupId': 'OG002'}, {'value': '0.027', 'spread': '0.072', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0327', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.217', 'ciLowerLimit': '-0.416', 'ciUpperLimit': '-0.018', 'estimateComment': 'Least Squares Mean of "Avenciguat 1 mg TID" - Least Squares Mean of "Placebo".', 'groupDescription': 'Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.', 'statisticalMethod': 'Mixed-effect Model repeat Measurement', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0447', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.206', 'ciLowerLimit': '-0.408', 'ciUpperLimit': '-0.005', 'estimateComment': 'Least Squares Mean of "Avenciguat 2 mg TID" - Least Squares Mean of "Placebo".', 'groupDescription': 'Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.', 'statisticalMethod': 'Mixed-effect Model repeat Measurement', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0654', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.187', 'ciLowerLimit': '-0.387', 'ciUpperLimit': '0.012', 'estimateComment': 'Least Squares Mean of "Avenciguat 3 mg TID" - Least Squares Mean of "Placebo".', 'groupDescription': 'Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.', 'statisticalMethod': 'Mixed-effect Model repeat Measurement', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.', 'description': 'Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment is reported.\n\nLeast Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.\n\nThe first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. Log transformed UACR at Week 20 was log of (average of all available scheduled measurements between week 18 and week 20). The data in the Outcome Measure Data Table represent the Least Squares Mean (Standard error) at Week 20.', 'unitOfMeasure': 'log (mg/g)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all patients who had at least one baseline measurement of UACR in Week -2, -1, or 0 and at least 1 post-baseline measurement after Week 6.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Avenciguat 1 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Weeks 1 to 20 (included).\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Avenciguat 2 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg of avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 20 of treatment.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG002', 'title': 'Avenciguat 3 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg avenciguat (one film-coated tablet of 3 mg) TID occurred from Week 5 until Week 20.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants. Participants were administered film-coated tablets of placebo matching avenciguat 1mg, 2mg or 3mg 3 times a day (TID) during 20 weeks of treatment.\n\nPlacebo matching avenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0476', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.20', 'ciLowerLimit': '1.01', 'ciUpperLimit': '4.79', 'pValueComment': 'Nominal p-value.', 'estimateComment': 'Odds ratio (Avenciguat 1 mg TID vs. Placebo).', 'groupDescription': 'Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0119', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.72', 'ciLowerLimit': '1.25', 'ciUpperLimit': '5.94', 'pValueComment': 'Nominal p-value.', 'estimateComment': 'Odds ratio (Avenciguat 2 mg TID vs. Placebo).', 'groupDescription': 'Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0019', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.43', 'ciLowerLimit': '1.58', 'ciUpperLimit': '7.45', 'pValueComment': 'Nominal p-value.', 'estimateComment': 'Odds ratio (Avenciguat 3 mg TID vs. Placebo).', 'groupDescription': 'Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.', 'description': 'Number of patients achieving urine albumin creatinine ratio (UACR) decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment.\n\nDuring the 10-hour period every time the patient urinates, and the patient collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all patients who had at least one baseline measurement of UACR in Week -2, -1, or 0 and at least 1 post-baseline measurement after Week 6.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Avenciguat 1 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Weeks 1 to 20 (included).\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Avenciguat 2 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg of avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 20 of treatment.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG002', 'title': 'Avenciguat 3 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg avenciguat (one film-coated tablet of 3 mg) TID occurred from Week 5 until Week 20.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants. Participants were administered film-coated tablets of placebo matching avenciguat 1mg, 2mg or 3mg 3 times a day (TID) during 20 weeks of treatment.\n\nPlacebo matching avenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0497', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.13', 'ciLowerLimit': '1.00', 'ciUpperLimit': '4.55', 'pValueComment': 'Nominal p-value.', 'estimateComment': 'Odds ratio (Avenciguat 1 mg TID vs. Placebo).', 'groupDescription': 'Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0502', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.15', 'ciLowerLimit': '1.00', 'ciUpperLimit': '4.61', 'pValueComment': 'Nominal p-value.', 'estimateComment': 'Odds ratio (Avenciguat 2 mg TID vs. Placebo).', 'groupDescription': 'Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0572', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.09', 'ciLowerLimit': '0.98', 'ciUpperLimit': '4.49', 'pValueComment': 'Nominal p-value.', 'estimateComment': 'Odds ratio (Avenciguat 3 mg TID vs. Placebo).', 'groupDescription': 'Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.', 'description': 'Number of patients achieving urine albumin creatinine ratio (UACR) decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all patients who had at least one baseline measurement of UACR in Week -2, -1, or 0 and at least 1 post-baseline measurement after Week 6.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Avenciguat 1 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Weeks 1 to 20 (included).\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'FG001', 'title': 'Avenciguat 2 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg of avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 20 of treatment.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'FG002', 'title': 'Avenciguat 3 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg avenciguat (one film-coated tablet of 3 mg) TID occurred from Week 5 until Week 20.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants. Participants were administered film-coated tablets of placebo matching avenciguat 1mg, 2mg or 3mg 3 times a day (TID) during 20 weeks of treatment.\n\nPlacebo matching avenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomised to avenciguat or placebo matching avenciguat', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '66'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other reason than listed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Burden of study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Change of residence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Perceived lack of efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This trial was a Phase II, randomised, placebo-controlled, double-blind (within dose groups), parallel, multicentre clinical trial in patients with non-diabetic kidney disease (non-DKD) to demonstrate the effectiveness and safety of avenciguat and to characterize the dose-response relationship for avenciguat in patients with non-DKD by assessing 3 doses and placebo.', 'preAssignmentDetails': 'Patients underwent a screening period of up to 3 weeks from the time of informed consent. After confirmation of eligibility at screening, patients continued in a 2-week baseline run-in period. Patients who successfully completed the screening and baseline run-in periods and met the inclusion/exclusion criteria were randomised equally into 1 of 3 parallel dose groups, and in each dose group to treatment either with avenciguat or matching placebo in a 3:1 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '261', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Avenciguat 1 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Weeks 1 to 20 (included).\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'BG001', 'title': 'Avenciguat 2 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg of avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 20 of treatment.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'BG002', 'title': 'Avenciguat 3 mg TID', 'description': 'Patients received daily orally one film-coated tablet of 1 milligram (mg) of avenciguat three times a day (TID) in Week 1 and Week 2. If the 1 mg TID medication was tolerated, up-titration to 2 mg avenciguat (one film-coated tablet of 2 mg) TID occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg avenciguat (one film-coated tablet of 3 mg) TID occurred from Week 5 until Week 20.\n\nAvenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants. Participants were administered film-coated tablets of placebo matching avenciguat 1mg, 2mg or 3mg 3 times a day (TID) during 20 weeks of treatment.\n\nPlacebo matching avenciguat had to be taken with a glass of water and could be taken with or without food.\n\nPatients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '16.3', 'groupId': 'BG000'}, {'value': '60.4', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '15.0', 'groupId': 'BG002'}, {'value': '58.1', 'spread': '14.4', 'groupId': 'BG003'}, {'value': '58.1', 'spread': '15.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '181', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '194', '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': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '159', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sodium-glucose cotransporter 2 inhibitor (SGLT2i) use at randomization', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of patients in each category sodium-glucose cotransporter 2 inhibitor (SGLT2i) use at randomization. The reported categories of SGLT2i use at randomization are: Yes; No.', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline urine albumine creatinine ratio (UACR), 10-hour urine', 'classes': [{'categories': [{'measurements': [{'value': '1024.1', 'spread': '920.1', 'groupId': 'BG000'}, {'value': '868.2', 'spread': '727.7', 'groupId': 'BG001'}, {'value': '941.5', 'spread': '1155.2', 'groupId': 'BG002'}, {'value': '1076.2', 'spread': '1786.2', 'groupId': 'BG003'}, {'value': '977.6', 'spread': '1213.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline UACR measured in 10-hour urine is reported. UACR is a ratio between two measured substances i.e., albumine and creatinine and it is calculated as: (Urine albumin (milligram (mg)/deciliter (dL)))/(urine creatinine gram (g)/deciliter (dL))= UACR in mg/g. Albuminuria is present when UACR is greater than 30 mg/g and is a marker for chronic kidney disease (CKD). Baseline was defined as the mean of all non-missing assessments from visit 2 (Week -2) until prior to the first intake of trial medication.', 'unitOfMeasure': 'milligram/gram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Urine Albumine Creatinine Ratio (UACR) in First Morning Void (FMV)', 'classes': [{'categories': [{'measurements': [{'value': '879.1', 'spread': '840.8', 'groupId': 'BG000'}, {'value': '745.4', 'spread': '661.9', 'groupId': 'BG001'}, {'value': '821.3', 'spread': '1083.5', 'groupId': 'BG002'}, {'value': '874.1', 'spread': '1142.0', 'groupId': 'BG003'}, {'value': '829.9', 'spread': '949.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'UACR measured in FMV is reported. UACR is a ratio between two measured substances i.e., albumine and creatinine and it is calculated as: (urine albumin (milligram (mg)/deciliter (dL)))/(urine creatinine gram (g)/deciliter (dL))= UACR in mg/g. Albuminuria is present when UACR is greater than 30 mg/g and is a marker for chronic kidney disease (CKD). Baseline was defined as the mean of all non-missing assessments from visit 2 (Week -2) until prior to the first intake of trial medication.', 'unitOfMeasure': 'milligram/gram', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Randomised Set (RS): this patient set included all entered and randomised patients.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-15', 'size': 10296827, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-30T08:27', 'hasProtocol': True}, {'date': '2023-11-01', 'size': 1543679, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-30T08:27', 'hasProtocol': False}]}}, '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': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2021-02-01', 'resultsFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2021-02-01', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-08', 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2, Week -1, Week 0 pre-dose) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.', 'description': 'Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment is reported.\n\nLeast Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12, and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.\n\nLog transformed UACR at Week 20 was log of (average of all available scheduled measurements between week 18 and week 20).\n\nThe data in the Outcome Measure Data Table represent the Least Squares Mean (Standard error) at Week 20.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.', 'description': 'Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment is reported.\n\nLeast Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.\n\nThe first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. Log transformed UACR at Week 20 was log of (average of all available scheduled measurements between week 18 and week 20). The data in the Outcome Measure Data Table represent the Least Squares Mean (Standard error) at Week 20.'}, {'measure': 'Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment', 'timeFrame': 'At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.', 'description': 'Number of patients achieving urine albumin creatinine ratio (UACR) decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment.\n\nDuring the 10-hour period every time the patient urinates, and the patient collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample.'}, {'measure': 'Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment', 'timeFrame': 'At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.', 'description': 'Number of patients achieving urine albumin creatinine ratio (UACR) decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '38795055', 'type': 'DERIVED', 'citation': 'Heerspink HJL, Cherney D, Gafor AHA, Gorriz JL, Pergola PE, Tang SCW, Desch M, Iliev H, Sun Z, Steubl D, Nangaku M. Effect of Avenciguat on Albuminuria in Patients with CKD: Two Randomized Placebo-Controlled Trials. J Am Soc Nephrol. 2024 Sep 1;35(9):1227-1239. doi: 10.1681/ASN.0000000000000418. Epub 2024 May 25.'}], 'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study.\n\nParticipants get either one of the three doses of avenciguat or placebo. It is decided by chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or placebo as tablets 3 times a day. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call.\n\nKidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of avenciguat and placebo. During the study, the doctors also regularly check the general health of the participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.\n* Male or female patients aged ≥18 years at time of consent.\n* Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) ≥ 20 and \\< 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis. eGFR must remain ≥20 mL/min/1.73 m2 after Visit 1 up to the start of Visit 3, measured by central or any local laboratory analysis.\n* Urine albumin creatinine ratio (UACR) ≥ 200 and \\< 3,500 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.\n* Patients with macroalbuminuria (\\>300 mg/g) should be treated with the highest tolerated dose of either Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both). For patients with microalbuminuria the use of ACEi or ARB is at the discretion of the Investigator. Treatment should be at a stable dose for ≥ 4 weeks before Visit 1 with no planned change of the therapy during the trial.\n* If the patient is taking any of the following medications they should be on a stable dose at least 4 weeks prior to visit 1 until start of treatment, with no planned change of the therapy during the trial: anti-hypertensives, non-steroidal anti-inflammatory drugs (NSAIDs), endothelin receptor antagonists, systemic steroids or Sodium-glucose co-transporter-2 (SGLT2) inhibitors.\n* In the Investigator's judgment any kind of diagnosed chronic kidney disease whose primary cause is clinically not considered to be of diabetic origin.\n\nFurther inclusion criteria apply\n\nExclusion Criteria:\n\n* Treatment with Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either ACEi or ARB), Phosphodiesterase-5-inhibitors, non-specific phosphodiesterase inhibitors (such as dipyridamole and theophylline), Nitric Oxide (NO) donors including nitrates, soluble Guanylate Cyclase (sGC)-stimulators/activators (other than trial treatment) or any other restricted medication (including Organic Anion-Transporting Polypeptide 1B1 and 1B3 (OATP1B1/3) inhibitors, Uridine 5'-diphosphate -glucuronosyltransferase (UGT) inhibitors/inducers) as provided in the Investigator Site File (ISF) within 4 weeks prior to visit 1 and throughout screening and baseline run-in. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.\n* Any clinically relevant laboratory value from screening until start of trial treatment which, in the investigator's judgement, puts the patient at additional risk.\n* Diagnosed with diabetic kidney disease.\n* Any immunosuppression therapy or immunotherapy in last 3 months prior to visit 1 and throughout screening and baseline run-in (except prednisolone ≤10 mg or equivalent).\n* Acute kidney injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition in the 30 days prior to Visit 1 until the start of trial treatment.\n* Planned start of chronic renal replacement therapy during the trial or end stage renal disease before start of trial treatment.\n* Known history of moderate or severe symptomatic orthostatic dysregulation as judged by the investigator before start of trial treatment.\n* The patient has an active infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (or is known to have a positive test from screening until randomisation).\n* Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04736628', 'briefTitle': 'A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Randomised, Double-blind (Within Dose Groups), Placebo Controlled and Parallel Group Trial to Investigate the Effects of Different Doses of Oral BI 685509 Given Over 20 Weeks on UACR Reduction in Patients With Non-diabetic Kidney Disease', 'orgStudyIdInfo': {'id': '1366-0022'}, 'secondaryIdInfos': [{'id': '2020-002930-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avenciguat 1 mg TID', 'description': 'TID=ter in die (3 times a day)', 'interventionNames': ['Drug: Avenciguat']}, {'type': 'EXPERIMENTAL', 'label': 'Avenciguat 2 mg TID', 'interventionNames': ['Drug: Avenciguat']}, {'type': 'EXPERIMENTAL', 'label': 'Avenciguat 3 mg TID', 'interventionNames': ['Drug: Avenciguat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Avenciguat', 'type': 'DRUG', 'otherNames': ['BI 685509'], 'description': 'Avenciguat', 'armGroupLabels': ['Avenciguat 1 mg TID', 'Avenciguat 2 mg TID', 'Avenciguat 3 mg TID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91351', 'city': 'Canyon Country', 'state': 'California', 'country': 'United States', 'facility': 'Clearview Medical Research, LLC', 'geoPoint': {'lat': 34.42333, 'lon': -118.47203}}, {'zip': '91730', 'city': 'Rancho Cucamonga', 'state': 'California', 'country': 'United States', 'facility': 'Rancho Cucamonga Clinical Trials', 'geoPoint': {'lat': 34.1064, 'lon': -117.59311}}, {'zip': '92395', 'city': 'Victorville', 'state': 'California', 'country': 'United States', 'facility': 'Kidney & Hypertension Center', 'geoPoint': {'lat': 34.53611, 'lon': -117.29116}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Chase Medical Research, LLC', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nephrology Associates, P.A.', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research and Health Center', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33032', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Homestead Associates in Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bioclinical Research Alliance, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Alma Clinical Research, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Panax Clinical Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Davita Clinical Research', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Boise Kidney and Hypertension, PLLC', 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Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.\n\nThe data shared are the raw clinical study data sets.', 'accessCriteria': "For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}