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OpenTrials
Active, Not Recruiting

NCT Number: NCT02490904

Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eplerenone

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Iohexol clearance

    Time frame: 3 months

    Graft function at 3 months evaluated by GFR using iohexol clearance

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.

Acronym: EPURE

Important dates

Study start
2016
Primary completion
2021
Study completion
2031
First posted
Jul 7, 2015
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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