NCT02490904Active, not recruitingPhase 3
Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)
Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.
Source: ClinicalTrials.gov · Last updated 18 Jun 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 1 Jul 2015
- Start date
- 19 Oct 2016
- Primary completion date
- 9 Nov 2021
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Chronic kidney disease
- NCT number
- NCT02490904
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 132
- From 19 Oct 2016 to the primary completion date, 9 Nov 2021
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone)
- Preemptive transplantation
- Patient receiving powerful CYP3A4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone)
- HLA desensitization prior to renal transplantation
Other illness
- Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)
- Hypersensitivity or known allergy to Eplerenone or one of its excipients
- Patients with severe hepatic insufficiency (class Child-Pugh C)
- Hypersensitivity or known allergy to iodinated contrast agents (iohexol)
- Hypersensitivity to lactose
Other
- Peritoneal dialysis
- Demonstrated thyrotoxicosis
- Pregnant woman or woman without effective contraception
- Patient under judicial protection
- Patient under legal guardianship
- Participation in another biomedical study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chru Besancon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Chu Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHU Dijon- Hôpital Bocage Central Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHRU de Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| CHU Reims Hôpital Maison Blanche Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| NHC -CHRU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.