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Clinical Trial Details

Trial ID: L0856
Source ID: NCT02490904
Associated Drug: Eplerenone
Title: Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)
Acronym: EPURE
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: End-stage Renal Disease
Interventions: DRUG: Eplerenone|DRUG: Placebo
Outcome Measures: Primary: Iohexol clearance, Graft function at 3 months evaluated by GFR using iohexol clearance, 3 months | Secondary: Proportion of dialysis dependency, 3 months|Proportion of patients presenting a delayed graft function, 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, 7 days post transplantation|24-hour proteinuria, 3 months|Occurrence of hyperkalemia > 6 mmol/l, 7 days post transplant|Length of initial hospital stay, between transplantation and discharge, 1 month|Proportion of patients alive, vital status collected through the national database of organ recipients, 3 months 1 year, 3 years, 10 years|serum creatinine, using the enzymatic method, 3 months 1 year, 3 years, 10 years|glomerular filtration rate, estimation using the CKD-EPI formula (in mL/min/1.73m2), 3 months 1 year, 3 years, 10 years|Proportion of patients with immediate renal recovery,, 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, 7 days post transplant|Iohexol clearance < 30 mL/min/1,73m², 3 months|24-hour microalbuminuria, 3 months|Proportion of patients with a slow renal recovery, 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, 7 days post transplant|Proportion of patients with biopsy-proven acute rejection, Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation, 3 months post transplant
Sponsor/Collaborators: Sponsor: Central Hospital, Nancy, France
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 132
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-10-19
Completion Date: 2031-08
Results First Posted:
Last Update Posted: 2023-06-18
Locations: CHRU Besançon, Besancon, France|CHU Brest, Brest, France|CHU Dijon- Hôpital Bocage Central, Dijon, France|CHRU de Nancy, Nancy, France|CHU Reims-Hôpital Maison Blanche, Reims, France|CHU Saint Etienne, Saint-Étienne, France|NHC -CHRU Strasbourg, Strasbourg, France
URL: https://clinicaltrials.gov/show/NCT02490904