Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-28 @ 3:33 AM
Study NCT ID:
NCT03020303
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia']}, 'interventionBrowseModule': {'meshes': [{'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2538}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CV Death or Hospitalization for Heart Failure', 'timeFrame': 'up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Cause specific death', 'timeFrame': 'up to 5 years'}, {'measure': 'Hospitalization for Heart Failure', 'timeFrame': 'up to 5 years'}, {'measure': 'All-cause death', 'timeFrame': 'up to 5 years'}, {'measure': 'All-cause Hospitalization', 'timeFrame': 'up to 5 years'}, {'measure': 'Hospitalization for hyperkalemia', 'timeFrame': 'up to 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endstage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '27265777', 'type': 'BACKGROUND', 'citation': 'Quach K, Lvtvyn L, Baigent C, Bueti J, Garg AX, Hawley C, Haynes R, Manns B, Perkovic V, Rabbat CG, Wald R, Walsh M. The Safety and Efficacy of Mineralocorticoid Receptor Antagonists in Patients Who Require Dialysis: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2016 Oct;68(4):591-598. doi: 10.1053/j.ajkd.2016.04.011. Epub 2016 Jun 3.'}, {'pmid': '26138259', 'type': 'BACKGROUND', 'citation': 'Walsh M, Manns B, Garg AX, Bueti J, Rabbat C, Smyth A, Tyrwhitt J, Bosch J, Gao P, Devereaux PJ, Wald R. The Safety of Eplerenone in Hemodialysis Patients: A Noninferiority Randomized Controlled Trial. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1602-8. doi: 10.2215/CJN.12371214. Epub 2015 Jul 2.'}, {'pmid': '40818850', 'type': 'DERIVED', 'citation': 'Walsh M, Collister D, Gallagher M, Mark PB, de Zoysa JR, Tyrwhitt J, Tennankore K, Reis G, Xavier D, Liu WJ, Zuo L, Wang AY, Felix C, Sola L, Arici M, Villanueva R, Jha V, Precoma D, Rabbat CG, Alavudeen SS, Faruqui AR, Lopez-Flecher M, Pyne L, Wald R, Yuan F, Balasubramanian K, Lee SF, Kuptsova A, Christou C, Devereaux PJ; ACHIEVE Investigators. Spironolactone versus placebo in patients undergoing maintenance dialysis (ACHIEVE): an international, parallel-group, randomised controlled trial. Lancet. 2025 Aug 16;406(10504):695-704. doi: 10.1016/S0140-6736(25)01198-5.'}, {'pmid': '40470466', 'type': 'DERIVED', 'citation': 'Walsh M, Collister D, Gallagher M, Mark PB, de Zoysa JR, Tyrwhitt J, Tennankore K, Sola L, Reis G, Xavier D, Villanueva R, Liu WJ, Felix C, Zuo L, Arici M, Jha V, Wald R, Wang AY, Faruqui AR, Yuan F, Lee SF, Kuptsova A, Christou C, Devereaux PJ; ACHIEVE Investigators. The Aldosterone Blockade for Health Improvement Evaluation in End-Stage Renal Disease (ACHIEVE) Trial: Rationale and Clinical Research Protocol. Can J Kidney Health Dis. 2025 Jun 3;12:20543581251348187. doi: 10.1177/20543581251348187. eCollection 2025.'}, {'pmid': '38289999', 'type': 'DERIVED', 'citation': 'Huang B, McDowell G, Rao A, Lip GYH. Mineralocorticoid receptor antagonist for chronic kidney disease, risk or benefit? J Hypertens. 2024 Mar 1;42(3):396-398. doi: 10.1097/HJH.0000000000003643. Epub 2024 Feb 1. No abstract available.'}, {'pmid': '34117077', 'type': 'DERIVED', 'citation': 'Soomro QH, Charytan DM. Mineralocorticoid Receptor Antagonists and Cardiovascular Health with Kidney Failure. Clin J Am Soc Nephrol. 2021 Jun;16(6):843-845. doi: 10.2215/CJN.04460421. No abstract available.'}, {'pmid': '34098039', 'type': 'DERIVED', 'citation': 'Collister D, Mbuagbaw L, Guyatt G, Devereaux PJ, Tennankore KK, Reis G, Sola L, Xavier D, Jha V, Gallagher M, Dans AL, Liu W, de Zoysa J, Felix C, Mark PB, Li Z, Tyrwhitt J, Wilkinson J, Sheridan P, Yuan F, Walsh M; ACHIEVE investigators. Three week compared to seven week run-in period length and the assessment of pre-randomization adherence: A study within a trial. Contemp Clin Trials. 2021 Aug;107:106466. doi: 10.1016/j.cct.2021.106466. Epub 2021 Jun 5.'}, {'pmid': '33586138', 'type': 'DERIVED', 'citation': 'Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Individuals receiving dialysis are at risk of heart failure and heart related death. There is an urgent need for treatments that reduce the risk of these problems in patients that require dialysis.\n\nSpironolactone is a pill used to prevent heart failure and related deaths in patients that do not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes high blood pressure and can damage the heart. Although spironolactone is very effective in patients that do not require dialysis, we do not know if spironolactone is effective in dialysis patients. Our research will help determine if spironolactone reduces heart failure and heart related deaths in dialysis patients.\n\nThe purpose of this study is to determine if spironolactone reduces death or hospitalization for heart failure and is well tolerated in patients that require dialysis.', 'detailedDescription': 'Globally, over 2 million people receive dialysis for end-stage renal disease (ESRD) and 650,000 new patients start dialysis each year. Furthermore, the number of patients receiving dialysis is increasing as access to dialysis in the developing world improves and the prevalence of diabetes and vascular disease rises. Despite technical advances in dialysis, the outcomes for patients with ESRD are poor. Patients have frequent hospitalizations, poor health related quality of life and strikingly, high mortality rates.\n\nThe most common cause of death in patients receiving dialysis is cardiovascular disease, accounting for \\>40% of all deaths. Observational studies suggest a causal pathway to cardiovascular death that includes progressive ventricular hypertrophy and dilatation as well as accelerated atherosclerosis. These changes result in myocardial ischemia and cardiac fibrosis that, in turn, lead to heart failure, arrhythmias and cardiac arrest. Strongly implicated in this pathophysiology is aldosterone. Mineralocorticoid receptor antagonists (MRAs) in non-ESRD patients, prevent cardiovascular deaths and small randomized controlled trials of MRAs in ESRD suggests they may reduce death and may be safe.\n\nSpironolactone is the most commonly used MRA worldwide. We will conduct a multicentre randomized controlled trial (RCT) to determine if spironolactone reduces cardiac mortality and hospitalizations for heart failure in patients treated with dialysis. This trial is called the Aldosterone bloCkade for Health Improvement EValuation in End-stage renal disease (ACHIEVE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age\n\n 1. ≥45 years or\n 2. ≥18 with a history of diabetes\n2. On dialysis ≥ 90 days\n3. On either\n\n 1. Hemodialysis prescribed at least 2 treatments per week or\n 2. Peritoneal dialysis prescribed with at least 1 exchange daily\n4. Provides informed consent\n\nExclusion Criteria:\n\n1. Hyperkalemia\n\n 1. Serum potassium \\>5.8 mmol/L in the 6 weeks prior to enrollment or\n 2. Serum potassium \\>6.0 mmol/L during active run-in\n2. Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone).\n3. Known sensitivity or allergy to spironolactone\n4. Current or planned pregnancy or breastfeeding\n5. Scheduled living related donor renal transplant\n6. Life expectancy \\< 6 months in the opinion of a treating nephrologist.\n7. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone.\n8. Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated'}, 'identificationModule': {'nctId': 'NCT03020303', 'acronym': 'ACHIEVE', 'briefTitle': 'Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease', 'orgStudyIdInfo': {'id': 'ACHIEVE Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Tablet', 'description': 'A tablet with no active medication that will be an exact match of the active spironolactone in taste and appearance', 'interventionNames': ['Drug: Placebo Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spironolactone 25 MG Tablet', 'description': '25 mg of active spironolactone in tablet form', 'interventionNames': ['Drug: Spironolactone 25Mg Tablet']}], 'interventions': [{'name': 'Spironolactone 25Mg Tablet', 'type': 'DRUG', 'description': 'Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.', 'armGroupLabels': ['Spironolactone 25 MG Tablet']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Randomized participants will receive a study supply of placebo tablets with no active medical ingredients. They will be instructed to take 1 tablet daily.', 'armGroupLabels': ['Placebo Oral Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Garran', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Concord Repatriation General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '2086', 'city': 'Frenchs Forest', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Northern Beaches Hospital', 'geoPoint': {'lat': -33.74821, 'lon': 151.22322}}, {'zip': '2076', 'city': 'Wahroonga', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '2076', 'city': 'Wahroonga', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Adventist Hospital', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '4575', 'city': 'Birtinya', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Sunshine Coast University Hospital', 'geoPoint': {'lat': -26.74322, 'lon': 153.11913}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Royal Brisbane Women's Hospital', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Health', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3021', 'city': 'Saint Albans', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Western Health - Sunshine Hospital', 'geoPoint': {'lat': -37.73333, 'lon': 144.8}}, {'zip': '30150221', 'city': 'Santa Efigênia', 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Miyun District Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Tongren Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Emergency General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': 'Faw General Hospital of Jilin Province', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Enshi', 'country': 'China', 'facility': 'The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture', 'geoPoint': {'lat': 30.3, 'lon': 109.48333}}, {'city': "Huai'an", 'country': 'China', 'facility': "Huai'an First Peoples Hospital", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}, {'city': 'Kunming', 'country': 'China', 'facility': 'The First Hospital of Kunming', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Lanzhou', 'country': 'China', 'facility': 'Gansu Baoshihua Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Luoyang', 'country': 'China', 'facility': 'Yichuan County Traditional Chinese Medicine Hospital', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Tongji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Provincial Peoples Hospital', 'geoPoint': {'lat': 44.00313, 'lon': 126.21057}}, {'city': 'Suqian', 'country': 'China', 'facility': 'Shuyang County Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 33.94917, 'lon': 118.29583}}, {'city': 'Suqian', 'country': 'China', 'facility': 'Sihong County Fenjinting Hospital', 'geoPoint': {'lat': 33.94917, 'lon': 118.29583}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Fifth Central Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin 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