Trial record 14 of 34 for:    eplerenone | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2016 by Central Hospital, Nancy, France
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT02490904
First received: July 1, 2015
Last updated: January 28, 2016
Last verified: January 2016
  Purpose
Evaluate the impact of eplerenon (administrated during 4 days in immediate pre-operative and 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.

Condition Intervention Phase
End-stage Renal Disease
Drug: Eplerenon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Placebo-Controlled Randomised Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenon After Renal Tranplantation : Effect on Graft Function at 3 Months.

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Iohexol clearance [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequence of dialysis requirement [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Proportion of patients presenting a delayed graft function [ Time Frame: 7 days post transplant ] [ Designated as safety issue: Yes ]
    The proportion of patients with a delayed graft function defined by the need of dialysis within the 7 days following transplant

  • 24 hours proteinuria [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Occurence of hyperkaliemia > 6 mmol/l [ Time Frame: 7 days post transplant ] [ Designated as safety issue: Yes ]
  • Lengths of initial hospital stay [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]
    between transplantation and discharge

  • Proportion of patients alive [ Time Frame: 1 year, 3 years, 10 years ] [ Designated as safety issue: No ]
    vital status collected through the national database of organ recipients

  • creatiniemia [ Time Frame: 1 year, 3 years, 10 years ] [ Designated as safety issue: No ]
    using the enzymatic method

  • glomerular filtration rate [ Time Frame: 1 year, 3 years, 10 years ] [ Designated as safety issue: No ]
    estimation using the CKD-EPI formula (in mL/min/1.73m2)

  • Proportion of patients with an immediate renal recovery, [ Time Frame: 7 days post transplant ] [ Designated as safety issue: Yes ]
    The proportion of patients with an immediate renal recovery is defined by a creatininemia lower than 30 mg/L at 7 days post-transplant

  • Iohexol clearance < 30 mL/min/1,73m² [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 24 hours microalbuminuria [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Proportion of patients with a slow renal recovery [ Time Frame: 7 days post transplant ] [ Designated as safety issue: Yes ]
    The proportion of patients with a slow renal recovery is defined by creatininemia above 30 mg/L at 7 days post-transplant without need for dialysis

  • Proportion of patients with a delayed graft function [ Time Frame: 7 days post transplant ] [ Designated as safety issue: Yes ]
    The proportion of patients with a delayed graft function is defined by the need for dialysis at 7 days post-transplant


Estimated Enrollment: 132
Study Start Date: May 2016
Estimated Study Completion Date: May 2030
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eplerenon group
Eplerenon administration just before and after renal tranplantation for 4 days and followed for 3 months and at 1, 3, 10 years post transplant
Drug: Eplerenon
Double blinded Eplerenon administrated for 4 days at 25mg each 12 hours
Placebo Comparator: Placebo group
Placebo administration just before and after renal tranplantation for 4 days and followed for 3 months and at 1, 3, 10 years post transplant
Drug: Placebo
Double blinded Placebo administrated for 4 days at 25mg each 12 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18
  • Informed consent
  • Candidate for a single or a dual kidney transplantation from a expanded criteria deceased donor (older than 60 years or age between 50 and 59 with 2 of the 3 follonwing criteria: cardiovascular death, history of hypertension, creatinemia above 130µmol/L), receving one or two kidneys, with or without conservation on perfusion machine
  • Chronic hemodialysis
  • Affiliated to social security system

Exclusion Criteria:

  • Multiple organs transplant (kidney and liver, kidney and heart, kidney and pancréas, kidney and lung, kidney and intestine)
  • Peritoneal dialysis
  • Preemptive transplantation
  • Hypersensitivity or known allergy to Eplerenon or one of its excipients
  • Patients with severe hepatic insufficiency (class Child-Pugh C)
  • Patient receving powerful inhibitors of CYP3A4 (for example itraconazole, kétoconazole, ritonavir, nelfinavir, clarithromycine, télithromycine and néfazodone)
  • Hypersensitivity or known allergy to iodized contrast agents (iohexol)
  • Demonstrated thyrotoxicosis
  • Hypersensitivity to lactose
  • HLA desensitization prior to renal transplantation
  • Pregnant woman or woman without efficient contraception
  • Patient under protection of justice
  • Patient under guardianship
  • Participation in another biomedical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02490904

Contacts
Contact: Frédéric JAISSER, Doctor +33 1 44278106 frederic.jaisser@inserm.fr
Contact: Sophie GIRERD, Doctor +33 383157322 s.girerd@chu-nancy.fr

Locations
France
CHRU Besançon Not yet recruiting
Besancon, France
Contact: Didier DUCLOUX         
Principal Investigator: Didier DUCLOUX         
CHU Dijon- Hôpital Bocage Central Not yet recruiting
Dijon, France
Contact: Christiane MOUSSON         
Principal Investigator: Christiane MOUSSON         
CHRU de Nancy Not yet recruiting
Nancy, France
Contact: Sophie GIRERD         
Principal Investigator: Sophie GIRERD         
AP-HP-Hôpital Henri Mondor Not yet recruiting
Paris, France
Contact: Philippe GRIMBERT         
Principal Investigator: Philippe GRIMBERT         
CHU Reims-Hôpital Maison Blanche Not yet recruiting
Reims, France
Contact: Philippe RIEU         
Principal Investigator: Philippe RIEU         
NHC -CHRU Strasbourg Not yet recruiting
Strasbourg, France
Contact: Bruno MOULIN         
Principal Investigator: Bruno MOULIN         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Frédéric JAISSER, Doctor CHRU Nancy
Principal Investigator: Sophie GIRERD, Doctor CHRU Nancy
  More Information

No publications provided

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02490904     History of Changes
Other Study ID Numbers: 2015-000956-29 
Study First Received: July 1, 2015
Last Updated: January 28, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Central Hospital, Nancy, France:
Kidney transplantation
Eplerenon

Additional relevant MeSH terms:
Eplerenone
Kidney Failure, Chronic
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 04, 2016