Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 112 for:    EPLERENONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02490904
Recruitment Status : Recruiting
First Posted : July 7, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Drug: Eplerenone Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: Eplerenone group
Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation.
Drug: Eplerenone
Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours

Placebo Comparator: Placebo group
Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation
Drug: Placebo
Double-blinded Placebo administered for 4 days at 25mg every 12 hours




Primary Outcome Measures :
  1. Iohexol clearance [ Time Frame: 3 months ]
    Graft function at 3 months evaluated by GFR using iohexol clearance


Secondary Outcome Measures :
  1. Proportion of dialysis dependency [ Time Frame: 3 months ]
  2. Proportion of patients presenting a delayed graft function [ Time Frame: 7 days post transplantation ]
    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

  3. 24-hour proteinuria [ Time Frame: 3 months ]
  4. Occurrence of hyperkalemia > 6 mmol/l [ Time Frame: 7 days post transplant ]
  5. Length of initial hospital stay [ Time Frame: 1 month ]
    between transplantation and discharge

  6. Proportion of patients alive [ Time Frame: 3 months 1 year, 3 years, 10 years ]
    vital status collected through the national database of organ recipients

  7. serum creatinine [ Time Frame: 3 months 1 year, 3 years, 10 years ]
    using the enzymatic method

  8. glomerular filtration rate [ Time Frame: 3 months 1 year, 3 years, 10 years ]
    estimation using the CKD-EPI formula (in mL/min/1.73m2)

  9. Proportion of patients with immediate renal recovery, [ Time Frame: 7 days post transplant ]
    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

  10. Iohexol clearance < 30 mL/min/1,73m² [ Time Frame: 3 months ]
  11. 24-hour microalbuminuria [ Time Frame: 3 months ]
  12. Proportion of patients with a slow renal recovery [ Time Frame: 7 days post transplant ]
    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

  13. Proportion of patients with biopsy-proven acute rejection [ Time Frame: 3 months post transplant ]
    Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490904


Contacts
Layout table for location contacts
Contact: Frédéric JAISSER, Doctor +33 1 44278106 frederic.jaisser@inserm.fr

Locations
Layout table for location information
France
CHRU Besançon Recruiting
Besancon, France
Contact: Didier DUCLOUX         
Principal Investigator: Didier DUCLOUX         
CHU Brest Recruiting
Brest, France
Contact: Yannick LE MEUR, Prof         
Principal Investigator: Yannick LE MEUR, Prof         
CHU Dijon- Hôpital Bocage Central Recruiting
Dijon, France
Contact: Christiane MOUSSON         
Principal Investigator: Christiane MOUSSON         
CHRU de Nancy Recruiting
Nancy, France
Contact: Sophie GIRERD         
Principal Investigator: Sophie GIRERD         
CHU Reims-Hôpital Maison Blanche Recruiting
Reims, France
Contact: Philippe RIEU         
Principal Investigator: Philippe RIEU         
CHU Saint Etienne Not yet recruiting
Saint-Étienne, France
Contact: Christophe MARIAT, Prof         
Principal Investigator: Christophe MARIAT, Prof         
NHC -CHRU Strasbourg Recruiting
Strasbourg, France
Contact: Bruno MOULIN         
Principal Investigator: Bruno MOULIN         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Layout table for investigator information
Principal Investigator: Frédéric JAISSER, Doctor CHRU Nancy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02490904     History of Changes
Other Study ID Numbers: 2015-000956-29
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Central Hospital, Nancy, France:
Kidney transplantation
Eplerenone
Additional relevant MeSH terms:
Layout table for MeSH terms
Eplerenone
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents