BridgeMD
Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months. EPURE TRANSPLANT
EU CTIS ID: 2024-517408-12-00
What this study is testing
To determine the impact of Eplerenone vs. placebo for 4 days before and immediately after transplantation on renal function assessed by glomerular filtration rate at 3 months post-kidney transplantation, a variable strongly associated with long-term graft survival.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)
- 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)
See the full eligibility 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
- Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)
- 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
- Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone)
- Peritoneal dialysis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.