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Study on the Effect of Eplerenone on Arterial Stiffness in Patients One Year After Kidney Transplant

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 studying the effects of a medication called eplerenone on patients who have undergone a kidney transplant. The purpose of the study is to understand how eplerenone affects the stiffness of arteries, which are the blood vessels that carry blood away from the heart, in patients who have had a kidney transplant at least one year ago. Eplerenone is taken as a film-coated tablet and is used to block certain receptors in the body that can affect blood pressure and heart health.

Participants in this study will be taking eplerenone for a period of six months. During this time, researchers will monitor changes in the stiffness of the arteries, as well as other health indicators such as blood pressure and heart function. The study will also look at how the medication affects the overall health of the kidney transplant, including how well the kidney is working and any changes in blood markers that indicate stress or damage to the blood vessels.

The study is designed to provide valuable information on the potential benefits of eplerenone for kidney transplant patients, particularly in managing the health of their blood vessels and heart. By understanding these effects, the study aims to improve the long-term health outcomes for individuals who have received a kidney transplant. Participants will be closely monitored throughout the study to ensure their safety and to gather comprehensive data on the effects of the medication.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, kidney transplant history, and current treatment with cyclosporine.
Informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This includes evaluating blood pressure and kidney function.
Measurements of pulse wave velocity and other cardiovascular parameters are taken using specialized equipment.
Step 3
Medication administration
The medication eplerenone is administered in the form of a film-coated tablet called INSPRA 25 mg.
The medication is taken orally once daily for a duration of six months.
Step 4
Ongoing monitoring
Throughout the six-month period, regular monitoring of blood pressure and kidney function is conducted.
Additional assessments include measuring cardiovascular health indicators and biological markers of oxidative stress and endothelial function.
Step 5
Final assessment
At the end of the six-month treatment period, a final assessment is conducted to evaluate changes in pulse wave velocity and other health indicators.
The results are compared to the initial assessment to determine the impact of the treatment.

Who can join the trial?

8 criteria

Male or female who is **50 years of age or older**.
Patient who had a **kidney transplant** at least one year ago.
Patient treated with **cyclosporine**, a medication used to prevent organ rejection.
Patient whose health condition has been **stable for at least 3 months**. This means no changes in treatment that affect blood pressure, except for immunosuppressive drugs, and no episodes of organ rejection diagnosed in the last 3 months.
Patient with a **glomerular filtration rate** of at least 30 mL/min/1.73m². This is a measure of how well the kidneys are filtering waste from the blood.
Patient with a **peripheral PAS** (systolic blood pressure) of at least 110 mmHg, regardless of whether they are on blood pressure medication, including ACE inhibitors or sartan.
Patient who has **signed informed consent**, meaning they understand and agree to participate in the study.
Patient who is **affiliated with or a beneficiary of a social security system**.

Who cannot join the trial?

5 criteria

Patients who have not had a kidney transplant for at least one year cannot participate. A kidney transplant is a surgery to place a healthy kidney from a donor into a person whose kidneys no longer function properly.
Patients who are not taking cyclosporine cannot participate. Cyclosporine is a medication that helps prevent the body from rejecting a transplanted organ.
Patients who are not stable after their kidney transplant cannot participate. Being stable means that the patient's health condition is not changing or getting worse.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.

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Verified sites

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CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France

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Investigated drugs

Eplerenone
is a medication used in this trial to block the mineralocorticoid receptor. It is being studied for its potential to reduce arterial stiffness in patients who have received a kidney transplant. The trial aims to see how six months of treatment with eplerenone affects the blood vessels of these patients.
Cyclosporine
is a medication that kidney transplant patients are already taking to prevent their bodies from rejecting the new organ. It helps to suppress the immune system, reducing the risk of transplant rejection. In this trial, patients are on cyclosporine as part of their standard care.

Eplerenone

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 effects on arterial stiffness in kidney transplant patients. It is primarily used to treat high blood pressure and heart failure. Eplerenone works by blocking the mineralocorticoid receptor, which reduces the effects of aldosterone, a hormone that can cause water retention and increase blood pressure. It is classified as a selective aldosterone 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. This condition involves the body's immune system potentially attacking the new kidney, which can lead to complications. Over time, the transplanted kidney may experience changes in function, which can be monitored through various medical tests. Patients who have undergone kidney transplantation often require medications to prevent rejection and manage other health aspects. The success of the transplant can be influenced by factors such as blood pressure, kidney function, and the presence of other health conditions. Regular follow-up and monitoring are essential to ensure the long-term health of the transplanted kidney.