Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Eplerenone group Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation. |
Drug: Eplerenone
Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours
|
| Placebo Comparator: Placebo group Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation |
Drug: Placebo
Double-blinded Placebo administered for 4 days at 25mg every 12 hours
|
Outcome Measures
Primary Outcome Measures
- Iohexol clearance [3 months]
Graft function at 3 months evaluated by GFR using iohexol clearance
Secondary Outcome Measures
- Proportion of dialysis dependency [3 months]
- 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]
- Length of initial hospital stay [1 month]
between transplantation and discharge
- Proportion of patients alive [3 months 1 year, 3 years, 10 years]
vital status collected through the national database of organ recipients
- serum creatinine [3 months 1 year, 3 years, 10 years]
using the enzymatic method
- 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 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
- Iohexol clearance < 30 mL/min/1,73m² [3 months]
- 24-hour microalbuminuria [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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU Besançon | Besancon | France | ||
| 2 | CHU Brest | Brest | France | ||
| 3 | CHU Dijon- Hôpital Bocage Central | Dijon | France | ||
| 4 | CHRU de Nancy | Nancy | France | ||
| 5 | CHU Reims-Hôpital Maison Blanche | Reims | France | ||
| 6 | CHU Saint Etienne | Saint-Étienne | France | ||
| 7 | NHC -CHRU Strasbourg | Strasbourg | France |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
- Principal Investigator: Frédéric JAISSER, MD, CHRU de Nancy
- Study Chair: Sophie GIRERD, MD, CHRU de NANCY
- Study Chair: Nicolas GIRERD, MD, PhD, CHRU de Nancy
- Study Chair: Luc FRIMAT, MD, PhD, CHRU de Nancy
- Study Chair: Patrick ROSSIGNOL, MD, PhD, CHRU de Nancy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015-000956-29