Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Jul 6, 2015

Keywords

ClinConnect Summary

The EPURE TRANSPLANT trial is studying a medication called eplerenone to see how it affects kidney function in patients who are receiving a kidney transplant. The goal is to start giving eplerenone just before the surgery and continue for four days after. Researchers want to measure how well the new kidney is working three months later, as good kidney function is important for the long-term success of the transplant.

To participate in this trial, individuals need to be over 18 years old and eligible for a kidney transplant from a specific type of donor, usually older than 60 or with certain health conditions. Participants must also be on chronic hemodialysis, which is a treatment for kidney failure. However, some people may not qualify, such as those receiving multiple organ transplants or certain medications. If eligible, participants can expect to receive either eplerenone or standard care during their transplant process, and they will be closely monitored for kidney function afterward.

Gender

ALL

Eligibility 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