Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

NCT02490904 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 2015-000956-29
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 7

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

Keywords

Kidney transplantation; Eplerenone

Outcome Measures

Primary Outcomes (1)

• Iohexol clearance

  Graft function at 3 months evaluated by GFR using iohexol clearance

  3 months

Secondary Outcomes (13)

• Proportion of dialysis dependency

  3 months

• Proportion of patients presenting a delayed graft function

  7 days post transplantation

• 24-hour proteinuria

  3 months

• Occurrence of hyperkalemia > 6 mmol/l

  7 days post transplant

• Length of initial hospital stay

  1 month

Study Arms (2)

Eplerenone group

EXPERIMENTAL

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

Drug: Eplerenone

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Eplerenone DRUG

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

Eplerenone group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (7)

CHRU Besançon

Besançon, France

Location

CHU Brest

Brest, France

Location

CHU Dijon- Hôpital Bocage Central

Dijon, France

Location

CHRU de Nancy

Nancy, France

Location

CHU Reims-Hôpital Maison Blanche

Reims, France

Location

CHU Saint Etienne

Saint-Etienne, France

Location

NHC -CHRU Strasbourg

Strasbourg, France

Location

Related Publications (3)

• 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.

  PMID: 39082471 DERIVED

• 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.

  PMID: 33586138 DERIVED

• 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.

  PMID: 30376884 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Frédéric JAISSER, MD

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

• Sophie GIRERD, MD

  CHRU de NANCY

  STUDY CHAIR

• Nicolas GIRERD, MD, PhD

  CHRU de Nancy

  STUDY CHAIR

• Luc FRIMAT, MD, PhD

  CHRU de Nancy

  STUDY CHAIR

• Patrick ROSSIGNOL, MD, PhD

  CHRU de Nancy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study chair

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 7, 2015
• Study Start: October 19, 2016
• Primary Completion: November 9, 2021
• Study Completion (Estimated): August 1, 2031
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

FR (7)