Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

NCT ID: NCT02490904

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-19
• Study Completion Date: 2031-08-31

Brief 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.

Conditions

End-stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Eplerenone group

Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation.

Group Type: EXPERIMENTAL

Eplerenone

Intervention Type: DRUG

Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours

Placebo group

Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Double-blinded Placebo administered for 4 days at 25mg every 12 hours

Interventions

Eplerenone

Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours

Intervention Type: DRUG

Placebo

Double-blinded Placebo administered for 4 days at 25mg every 12 hours

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Pr. Nicolas GIRERD

Study chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frédéric JAISSER, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Nancy

Sophie GIRERD, MD

Role: STUDY_CHAIR

CHRU de NANCY

Nicolas GIRERD, MD, PhD

Role: STUDY_CHAIR

CHRU de Nancy

Luc FRIMAT, MD, PhD

Role: STUDY_CHAIR

CHRU de Nancy

Patrick ROSSIGNOL, MD, PhD

Role: STUDY_CHAIR

CHRU de Nancy

Locations

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

Countries

France

References

Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.

Reference Type: DERIVED

PMID: 39082471 (View on PubMed)

Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.

Reference Type: DERIVED

PMID: 33586138 (View on PubMed)

Girerd S, Frimat L, Ducloux D, Le Meur Y, Mariat C, Moulin B, Mousson C, Rieu P, Dali-Youcef N, Merckle L, Lepage X, Rossignol P, Girerd N, Jaisser F. EPURE Transplant (Eplerenone in Patients Undergoing Renal Transplant) study: study protocol for a randomized controlled trial. Trials. 2018 Oct 30;19(1):595. doi: 10.1186/s13063-018-2956-1.

Reference Type: DERIVED

PMID: 30376884 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-000956-29

Identifier Type: -

Identifier Source: org_study_id