Ireland
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Active, not recruiting Phase 3

Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

NCT02490904 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2016-10-19
Last updated
2023-06-18

Condition(s) studied

End-stage Renal Disease

Investigational drug(s) / intervention(s)

Eplerenone →Placebo

Eplerenone: Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours

Placebo: Double-blinded Placebo administered for 4 days at 25mg every 12 hours

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Iohexol clearance — 3 months
    Graft function at 3 months evaluated by GFR using iohexol clearance

Trial sites (7)

FacilityCityRegionStatus
CHRU Besançon Besançon 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-Etienne France
NHC -CHRU Strasbourg Strasbourg France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02490904 on ClinicalTrials.gov ↗ ← All trials in France