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Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT) (EPURE)

Primary Purpose

End-stage Renal Disease

Status
Active
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Eplerenone
Placebo
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring Kidney transplantation, Eplerenone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • CHRU Besançon
  • CHU Brest
  • CHU Dijon- Hôpital Bocage Central
  • CHRU de Nancy
  • CHU Reims-Hôpital Maison Blanche
  • CHU Saint Etienne
  • NHC -CHRU Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eplerenone group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Iohexol clearance
Graft function at 3 months evaluated by GFR using iohexol clearance

Secondary Outcome Measures

Proportion of dialysis dependency
Proportion of patients presenting a delayed graft function
The proportion of patients with a delayed graft function defined by the need for one or more dialysis sessions during the 7 days following transplantation
24-hour proteinuria
Occurrence of hyperkalemia > 6 mmol/l
Length of initial hospital stay
between transplantation and discharge
Proportion of patients alive
vital status collected through the national database of organ recipients
serum creatinine
using the enzymatic method
glomerular filtration rate
estimation using the CKD-EPI formula (in mL/min/1.73m2)
Proportion of patients with immediate renal recovery,
The proportion of patients with an immediate renal recovery is defined by a serum creatinine lower than 30 mg/L at 7 days post-transplant
Iohexol clearance < 30 mL/min/1,73m²
24-hour microalbuminuria
Proportion of patients with a slow renal recovery
The proportion of patients with slow renal recovery is defined by serum creatinine above 30 mg/L at 7 days post-transplant without the need for dialysis
Proportion of patients with biopsy-proven acute rejection
Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation

Full Information

First Posted
July 1, 2015
Last Updated
June 16, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02490904
Brief Title
Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)
Acronym
EPURE
Official Title
Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2016 (Actual)
Primary Completion Date
November 9, 2021 (Actual)
Study Completion Date
August 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
Kidney transplantation, Eplerenone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eplerenone group
Arm Type
Experimental
Arm Description
Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Intervention Description
Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Double-blinded Placebo administered for 4 days at 25mg every 12 hours
Primary Outcome Measure Information:
Title
Iohexol clearance
Description
Graft function at 3 months evaluated by GFR using iohexol clearance
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion of dialysis dependency
Time Frame
3 months
Title
Proportion of patients presenting a delayed graft function
Description
The proportion of patients with a delayed graft function defined by the need for one or more dialysis sessions during the 7 days following transplantation
Time Frame
7 days post transplantation
Title
24-hour proteinuria
Time Frame
3 months
Title
Occurrence of hyperkalemia > 6 mmol/l
Time Frame
7 days post transplant
Title
Length of initial hospital stay
Description
between transplantation and discharge
Time Frame
1 month
Title
Proportion of patients alive
Description
vital status collected through the national database of organ recipients
Time Frame
3 months 1 year, 3 years, 10 years
Title
serum creatinine
Description
using the enzymatic method
Time Frame
3 months 1 year, 3 years, 10 years
Title
glomerular filtration rate
Description
estimation using the CKD-EPI formula (in mL/min/1.73m2)
Time Frame
3 months 1 year, 3 years, 10 years
Title
Proportion of patients with immediate renal recovery,
Description
The proportion of patients with an immediate renal recovery is defined by a serum creatinine lower than 30 mg/L at 7 days post-transplant
Time Frame
7 days post transplant
Title
Iohexol clearance < 30 mL/min/1,73m²
Time Frame
3 months
Title
24-hour microalbuminuria
Time Frame
3 months
Title
Proportion of patients with a slow renal recovery
Description
The proportion of patients with slow renal recovery is defined by serum creatinine above 30 mg/L at 7 days post-transplant without the need for dialysis
Time Frame
7 days post transplant
Title
Proportion of patients with biopsy-proven acute rejection
Description
Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation
Time Frame
3 months post transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric JAISSER, MD
Organizational Affiliation
CHRU de Nancy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sophie GIRERD, MD
Organizational Affiliation
CHRU de NANCY
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, MD, PhD
Organizational Affiliation
CHRU de Nancy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luc FRIMAT, MD, PhD
Organizational Affiliation
CHRU de Nancy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrick ROSSIGNOL, MD, PhD
Organizational Affiliation
CHRU de Nancy
Official's Role
Study Chair
Facility Information:
Facility Name
CHRU Besançon
City
Besancon
Country
France
Facility Name
CHU Brest
City
Brest
Country
France
Facility Name
CHU Dijon- Hôpital Bocage Central
City
Dijon
Country
France
Facility Name
CHRU de Nancy
City
Nancy
Country
France
Facility Name
CHU Reims-Hôpital Maison Blanche
City
Reims
Country
France
Facility Name
CHU Saint Etienne
City
Saint-Étienne
Country
France
Facility Name
NHC -CHRU Strasbourg
City
Strasbourg
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33586138
Citation
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.
Results Reference
derived
PubMed Identifier
30376884
Citation
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.
Results Reference
derived

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Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

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