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Study on Eplerenone for Improving Kidney Function in Patients Undergoing Kidney Transplantation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with end-stage renal disease who are candidates for a kidney transplant. The study is investigating the effects of a medication called Eplerenone, which is a type of drug known as a mineralocorticoid receptor blocker. This medication will be compared to a placebo to see how it affects kidney function after transplantation. The main goal is to understand how Eplerenone impacts the kidney's ability to filter blood, which is measured by something called the glomerular filtration rate, three months after the transplant.

Participants in the study will receive either Eplerenone or a placebo for four days before and immediately after their kidney transplant. The study will monitor various aspects of kidney health and overall well-being, including the clearance of a substance called Iohexol at three months, which helps assess kidney function. Other factors being observed include the need for dialysis, the occurrence of delayed graft function, protein levels in urine, and any episodes of high potassium levels, known as hyperkalemia, within the first week after the transplant.

The study will also track the length of the initial hospital stay, the survival rate of patients, and the kidney's filtration rate over time, up to ten years after the transplant. Additionally, the occurrence of any acute rejection of the transplanted kidney will be recorded. This research aims to provide valuable insights into improving long-term outcomes for kidney transplant recipients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will be informed about the study's purpose and procedures. The patient must provide informed consent, confirming understanding and willingness to participate.

  2. Step 2

    Pre-transplantation phase

    Four days before the kidney transplantation, the patient will begin taking the medication eplerenone. This medication is administered orally in the form of a film-coated tablet. The dosage and frequency will be specified by the healthcare provider.

  3. Step 3

    Transplantation and immediate post-transplantation phase

    The patient will undergo kidney transplantation. Immediately after the procedure, the patient will continue taking eplerenone as prescribed. The healthcare team will monitor the patient's condition closely during this period.

  4. Step 4

    Monitoring and follow-up

    The patient's kidney function will be assessed at 3 months post-transplantation. This includes measuring the glomerular filtration rate, which indicates how well the kidneys are working.

    Additional assessments will include checking for dialysis dependency, delayed graft function, protein levels in urine, and any occurrence of high potassium levels in the blood.

    The length of the initial hospital stay will be recorded, and the patient's overall health and kidney function will be monitored at 3 months, 1 year, 3 years, and 10 years post-transplantation.

Who can join the trial?

5 criteria

  • Patients must be older than 18 years of age.
  • Patients must provide informed consent, which means they understand the study and agree to participate.
  • Patients must be a candidate for a kidney transplant from a specific type of donor. This donor is either 60 years or older, or between 50 and 59 years old with certain health conditions.
  • Patients must be undergoing chronic hemodialysis, a treatment that helps clean the blood when the kidneys are not working well.
  • Patients must be affiliated with a social security system, meaning they have access to healthcare services through a government or private program.

Who cannot join the trial?

4 criteria

  • Patients who are not candidates for a kidney transplant.
  • Patients who are not in end-stage renal disease.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population.
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Investigated drugs

Eplerenone is a medication used in this clinical trial to help improve kidney function after a kidney transplant. It works by blocking certain hormones in the body that can cause damage to the kidneys. By doing this, Eplerenone may help the new kidney work better and last longer. In this study, researchers are looking at how Eplerenone affects kidney function when given for a few days before and after the transplant surgery.

What is already known about the treatment

Eplerenone – Eplerenone is administered orally in tablet form and is currently being studied in clinical trials for its potential benefits in patients undergoing kidney transplantation. It is primarily used to help improve kidney function in patients who have received a kidney transplant. Eplerenone works by blocking certain receptors in the body, which helps to reduce the effects of hormones that can cause damage to the kidneys. It is classified as a mineralocorticoid receptor antagonist, which means it helps to protect the kidneys by preventing harmful substances from affecting them.

Investigated diseases

End-Stage Renal Disease – End-stage renal disease (ESRD) is the final stage of chronic kidney disease where the kidneys can no longer function adequately to meet the body's needs. In this stage, the kidneys lose their ability to filter waste and excess fluids from the blood, leading to a buildup of toxins in the body. Patients with ESRD often require dialysis or a kidney transplant to survive. The progression to ESRD is typically gradual, occurring over several years as kidney function declines. Symptoms may include fatigue, swelling, shortness of breath, and changes in urination patterns. Without intervention, the condition can severely impact quality of life due to the accumulation of waste products in the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517408-12-00Estimated enrolment132 patientsSponsorCHRU De Nancy

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