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Trial record 1 of 1 for:    NCT02490904
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Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT) (EPURE)

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ClinicalTrials.gov Identifier: NCT02490904
Recruitment Status : Active, not recruiting
First Posted : July 7, 2015
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Pr Patrick ROSSIGNOL, Central Hospital, Nancy, France

Study Description
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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

Study Design
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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 19, 2016
Actual Primary Completion Date : November 9, 2021
Estimated Study Completion Date : August 2031

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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


Locations
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France
CHRU Besançon
Besancon, 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-Étienne, France
NHC -CHRU Strasbourg
Strasbourg, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Frédéric JAISSER, MD CHRU de Nancy
Study Chair: 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pr Patrick ROSSIGNOL, Professor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02490904    
Other Study ID Numbers: 2015-000956-29
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: September 2022
Keywords provided by Pr Patrick ROSSIGNOL, Central Hospital, Nancy, France:
Kidney transplantation
Eplerenone
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Eplerenone
Mineralocorticoid Receptor Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents