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ACTIVE_NOT_RECRUITINGPHASE3

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.

NCT02490904•Central Hospital, Nancy, France

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (7)

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

Key Dates

Start Date

October 19, 2016

Primary Completion Date

November 9, 2021

Completion Date

August 1, 2031

Last Updated

June 18, 2023

Enrollment

132

ESTIMATED participants

Conditions

End-stage Renal Disease

Interventions

Eplerenone

DRUG

Placebo

DRUG

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

NCT04634916

Kidney Disease, End-StageEnd-stage Renal Disease+1 more

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RECRUITINGPHASE3

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

NCT06933472

HyperphosphatemiaChronic Kidney Disease, Receiving Dialysis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

Comparative Study of Prognosis and QOL Between APD-RPM and CAPD

IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure