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Study on Eplerenone for Heart Health in Kidney Transplant Patients Using Cyclosporine or Tacrolimus

Verified siteRegistered drugNo placebo

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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 who have undergone a kidney transplantation and are taking medications called calcineurin inhibitors, such as cyclosporine or tacrolimus. The study is investigating the effects of a medication called eplerenone, which is taken in the form of a tablet. Eplerenone works by blocking a hormone called aldosterone, which can help improve heart function.

The purpose of the study is to see how taking eplerenone for 36 weeks affects the heart health of kidney transplant patients. Participants will be randomly assigned to receive either eplerenone or a placebo. The study will monitor changes in heart structure and function using echocardiograms, which are ultrasound tests of the heart. Researchers will also track any major heart-related events, such as heart failure or heart attacks, during the study period.

Throughout the study, participants will have regular check-ups to assess their heart health and overall well-being. The study will also measure blood pressure and levels of certain substances in the blood that indicate heart and kidney function. The goal is to determine if eplerenone can provide heart health benefits for patients who have received a kidney transplant and are on long-term calcineurin inhibitor therapy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Introduction to the trial
Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the effects of eplerenone on heart health in individuals who have received a kidney transplant and are taking specific medications called calcineurin inhibitors.
The patient will be required to provide informed consent, confirming their understanding and agreement to participate in the trial.
Step 2
Initial assessment
The patient will undergo a clinical examination to ensure they meet the inclusion criteria, such as being at least 18 years old, having had a kidney transplant for over a year, and being on stable medication for at least three months.
An echocardiogram will be performed to check for specific heart conditions, such as increased heart muscle mass or enlarged heart chambers.
Step 3
Medication administration
The patient will begin taking eplerenone orally. The dosage and frequency will be determined by the study protocol and the patient's specific needs.
The treatment with eplerenone will continue for a duration of 36 weeks.
Step 4
Regular monitoring
Throughout the 36-week period, the patient will have regular check-ups to monitor heart health and kidney function.
Blood pressure and other heart-related parameters will be assessed at specific intervals, including at the start, 12 weeks, and 36 weeks into the trial.
Step 5
Final evaluation
At the end of the 36-week period, a comprehensive evaluation will be conducted to assess the impact of eplerenone on heart health and kidney function.
The results will include changes in heart muscle mass, heart chamber size, and other cardiovascular and kidney health indicators.

Who can join the trial?

11 criteria

Men or women who are **18 years or older**.
Patient must be part of a **social security scheme** or be a beneficiary of such a scheme.
Person must have had a **prior clinical examination** suitable for the clinical trial.
Must be a **kidney transplant patient** for at least one year.
Patient must be on long-term **ciclosporin or tacrolimus therapy**. These are medications used to prevent organ rejection.
Patient's health must be **stable for at least three months**. This means no changes in treatment that could affect blood pressure, except for immunosuppressive therapy, and no recent acute graft rejection.
Patient must have a **GFR (Glomerular Filtration Rate)** estimated using the CKD-EPI formula of **40 ml/min/1.73m² or higher**, measured within the last month. GFR is a test to check how well the kidneys are working.
Patient must have a **peripheral SBP (Systolic Blood Pressure)** of **110 mmHg or higher**, regardless of whether they are using blood pressure medication.
Patient must have certain **echocardiographic abnormalities** on a heart ultrasound done at the start of the study:
- **Indexed LV (Left Ventricular) mass** greater than **88 g/m² in women** or **102 g/m² in men**. This measures the size of the heart's left ventricle.
- And/or **Left atrial volume** greater than **34 ml/m²**. This measures the size of the left atrium of the heart.
- Patient must have **signed informed consent**, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

Patients who have not had a kidney transplant for more than one year cannot participate. A kidney transplant is a surgery to place a healthy kidney from a donor into someone whose kidneys no longer work properly.
Patients who are not taking calcineurin inhibitors cannot participate. Calcineurin inhibitors are medications that help prevent the body from rejecting a transplanted organ.
Patients who are younger than 18 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
Centre Hospitalier Universitaire De Nantes
Nantes, France
Verified
Hôpitaux Universitaires Strasbourg - Hôpital de Hautepierre
STRASBOURG, Alsace, France

Trial locations

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Investigated drugs

Eplerenone
is a medication used in this trial to block mineralocorticoid receptors. It is being studied for its potential to improve heart health by reducing cardiovascular events and making positive changes to the heart's structure in patients who have received a kidney transplant and are taking calcineurin inhibitors.
Cyclosporine
is a medication used to prevent the body from rejecting a transplanted kidney. It works by suppressing the immune system to help the body accept the new organ.
Tacrolimus
is another medication used to prevent organ rejection in kidney transplant recipients. Like cyclosporine, it helps suppress the immune system to ensure the transplanted kidney is not rejected by the body.

Eplerenone

What is already known about the treatment

Eplerenone – Eplerenone is administered orally in tablet form. It is currently being studied in clinical trials for its effects on heart health in patients who have undergone kidney transplantation and are receiving calcineurin inhibitors like cyclosporine or tacrolimus. The main therapeutic indication being explored is the improvement of heart function and structure in these patients. Eplerenone works by blocking mineralocorticoid receptors, which helps reduce blood pressure and prevent harmful cardiac changes. It is classified as a mineralocorticoid receptor antagonist.

Investigated diseases

Kidney Transplantation – Kidney transplantation is a medical procedure where a healthy kidney from a donor is placed into a person whose kidneys are no longer functioning properly. After the transplant, the recipient's body may initially accept or reject the new kidney. Over time, the transplanted kidney can help filter waste from the blood, regulate blood pressure, and maintain electrolyte balance. However, the recipient must take medications to prevent the immune system from attacking the new organ. The success of the transplant can be influenced by various factors, including the recipient's overall health and adherence to medical advice. Regular monitoring is essential to ensure the transplanted kidney continues to function effectively.