Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

• Status: Recruiting
• Trial end date: 2030-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France
• Treatments: Eplerenone; Spironolactone

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