Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-09 @ 6:19 PM
Study NCT ID:
NCT02490904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2015-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-14', 'size': 372880, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-14T12:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2031-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2015-07-01', 'studyFirstSubmitQcDate': '2015-07-06', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Iohexol clearance', 'timeFrame': '3 months', 'description': 'Graft function at 3 months evaluated by GFR using iohexol clearance'}], 'secondaryOutcomes': [{'measure': 'Proportion of dialysis dependency', 'timeFrame': '3 months'}, {'measure': 'Proportion of patients presenting a delayed graft function', 'timeFrame': '7 days post transplantation', 'description': 'The proportion of patients with a delayed graft function defined by the need for one or more dialysis sessions during the 7 days following transplantation'}, {'measure': '24-hour proteinuria', 'timeFrame': '3 months'}, {'measure': 'Occurrence of hyperkalemia > 6 mmol/l', 'timeFrame': '7 days post transplant'}, {'measure': 'Length of initial hospital stay', 'timeFrame': '1 month', 'description': 'between transplantation and discharge'}, {'measure': 'Proportion of patients alive', 'timeFrame': '3 months 1 year, 3 years, 10 years', 'description': 'vital status collected through the national database of organ recipients'}, {'measure': 'serum creatinine', 'timeFrame': '3 months 1 year, 3 years, 10 years', 'description': 'using the enzymatic method'}, {'measure': 'glomerular filtration rate', 'timeFrame': '3 months 1 year, 3 years, 10 years', 'description': 'estimation using the CKD-EPI formula (in mL/min/1.73m2)'}, {'measure': 'Proportion of patients with immediate renal recovery,', 'timeFrame': '7 days post transplant', 'description': 'The proportion of patients with an immediate renal recovery is defined by a serum creatinine lower than 30 mg/L at 7 days post-transplant'}, {'measure': 'Iohexol clearance < 30 mL/min/1,73m²', 'timeFrame': '3 months'}, {'measure': '24-hour microalbuminuria', 'timeFrame': '3 months'}, {'measure': 'Proportion of patients with a slow renal recovery', 'timeFrame': '7 days post transplant', 'description': 'The proportion of patients with slow renal recovery is defined by serum creatinine above 30 mg/L at 7 days post-transplant without the need for dialysis'}, {'measure': 'Proportion of patients with biopsy-proven acute rejection', 'timeFrame': '3 months post transplant', 'description': 'Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Kidney transplantation', 'Eplerenone'], 'conditions': ['End-stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '39082471', 'type': 'DERIVED', 'citation': 'Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.'}, {'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.'}, {'pmid': '30376884', 'type': 'DERIVED', 'citation': 'Girerd S, Frimat L, Ducloux D, Le Meur Y, Mariat C, Moulin B, Mousson C, Rieu P, Dali-Youcef N, Merckle L, Lepage X, Rossignol P, Girerd N, Jaisser F. EPURE Transplant (Eplerenone in Patients Undergoing Renal Transplant) study: study protocol for a randomized controlled trial. Trials. 2018 Oct 30;19(1):595. doi: 10.1186/s13063-018-2956-1.'}]}, 'descriptionModule': {'briefSummary': 'Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years of age\n* Informed consent\n* Candidate for a single or a dual kidney transplantation from an expanded criteria deceased donor ( 60 years or older or age between 50 and 59 with 2 of the 3 following criteria: cardiovascular death, history of hypertension, serum creatinine above 130µmol/L), regardless of machine perfusion and graft rank\n* Chronic hemodialysis\n* Affiliated to a social security system\n\nExclusion Criteria:\n\n* Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)\n* Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone)\n* Peritoneal dialysis\n* Preemptive transplantation\n* Hypersensitivity or known allergy to Eplerenone or one of its excipients\n* Patients with severe hepatic insufficiency (class Child-Pugh C)\n* Patient receiving powerful CYP3A4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone)\n* Hypersensitivity or known allergy to iodinated contrast agents (iohexol)\n* Demonstrated thyrotoxicosis\n* Hypersensitivity to lactose\n* HLA desensitization prior to renal transplantation\n* Pregnant woman or woman without effective contraception\n* Patient under judicial protection\n* Patient under legal guardianship\n* Participation in another biomedical study'}, 'identificationModule': {'nctId': 'NCT02490904', 'acronym': 'EPURE', 'briefTitle': 'Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.', 'orgStudyIdInfo': {'id': '2015-000956-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eplerenone group', 'description': 'Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation.', 'interventionNames': ['Drug: Eplerenone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Eplerenone', 'type': 'DRUG', 'description': 'Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours', 'armGroupLabels': ['Eplerenone group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Double-blinded Placebo administered for 4 days at 25mg every 12 hours', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'country': 'France', 'facility': 'CHRU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon- Hôpital Bocage Central', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Nancy', 'country': 'France', 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Reims', 'country': 'France', 'facility': 'CHU Reims-Hôpital Maison Blanche', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'NHC -CHRU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Frédéric JAISSER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Nancy'}, {'name': 'Sophie GIRERD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHRU de NANCY'}, {'name': 'Nicolas GIRERD, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHRU de Nancy'}, {'name': 'Luc FRIMAT, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHRU de Nancy'}, {'name': 'Patrick ROSSIGNOL, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHRU de Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study chair', 'investigatorFullName': 'Pr. Nicolas GIRERD', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}