Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)
- Conditions
- End-stage Renal Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT02490904
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 132
- Patients older than 18 years of age
- Informed consent
- 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
- Chronic hemodialysis
- Affiliated to a social security system
- Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)
- Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone)
- Peritoneal dialysis
- Preemptive transplantation
- Hypersensitivity or known allergy to Eplerenone or one of its excipients
- Patients with severe hepatic insufficiency (class Child-Pugh C)
- Patient receiving powerful CYP3A4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone)
- Hypersensitivity or known allergy to iodinated contrast agents (iohexol)
- Demonstrated thyrotoxicosis
- Hypersensitivity to lactose
- HLA desensitization prior to renal transplantation
- Pregnant woman or woman without effective contraception
- Patient under judicial protection
- Patient under legal guardianship
- Participation in another biomedical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation Eplerenone group Eplerenone Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation.
- Primary Outcome Measures
Name Time Method Iohexol clearance 3 months Graft function at 3 months evaluated by GFR using iohexol clearance
- Secondary Outcome Measures
Name Time Method 24-hour microalbuminuria 3 months Length of initial hospital stay 1 month between transplantation and discharge
Proportion of patients with biopsy-proven acute rejection 3 months post transplant Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation
glomerular filtration rate 3 months 1 year, 3 years, 10 years estimation using the CKD-EPI formula (in mL/min/1.73m2)
Proportion of patients presenting a delayed graft function 7 days post transplantation 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
24-hour proteinuria 3 months Occurrence of hyperkalemia > 6 mmol/l 7 days post transplant Proportion of patients alive 3 months 1 year, 3 years, 10 years vital status collected through the national database of organ recipients
Proportion of patients with immediate renal recovery, 7 days post transplant 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
Proportion of dialysis dependency 3 months serum creatinine 3 months 1 year, 3 years, 10 years using the enzymatic method
Iohexol clearance < 30 mL/min/1,73m² 3 months Proportion of patients with a slow renal recovery 7 days post transplant 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
Trial Locations
- Locations (7)
CHU Dijon- Hôpital Bocage Central
🇫🇷Dijon, France
CHRU Besançon
🇫🇷Besancon, France
CHU Brest
🇫🇷Brest, France
CHRU de Nancy
🇫🇷Nancy, France
CHU Reims-Hôpital Maison Blanche
🇫🇷Reims, France
CHU Saint Etienne
🇫🇷Saint-Étienne, France
NHC -CHRU Strasbourg
🇫🇷Strasbourg, France