Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized crossover clinical trial regarding the blockage of the mineralocorticoid receptor using Eplerenone on the evolution of arterial stiffness in kidney patients one year after transplant: EVATRAN (The effect of Eplerenone on the evolution of Vasculopathy in renal transplant patients).

This research trial, called EVATRAN, is investigating a medicine called eplerenone (also known as Inspra) in people who have had a kidney transplant. The main goal is to understand if this drug can help reduce the stiffness of their blood vessels. Stiff blood vessels can be a problem in kidney disease and after transplant, potentially leading to heart issues. Over six months, participants will take eplerenone, and doctors will carefully measure changes in their blood vessel stiffness and blood pressure. The study also looks at other aspects of heart health, kidney function, and general well-being. This is a crossover trial, meaning participants might try both eplerenone and a placebo (dummy pill) at different times.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

CHRU De Nancy

Enrolment target

Start

07 Aug 2024

kidney transplantation

What is this study about?

This clinical trial is designed to investigate a medicine called eplerenone, also known by its brand name Inspra, in patients who have recently received a kidney transplant. When someone has kidney disease or receives a new kidney, their blood vessels can become stiff, which can put a strain on their heart and increase the risk of other health problems. The researchers want to find out if eplerenone can help make these blood vessels less stiff and improve overall heart and blood vessel health in these patients.

Over a period of six months, participants will take eplerenone, and doctors will perform various measurements. The primary focus is on something called 'pulse wave velocity' (PWV), which is a way to measure how stiff your arteries are. The slower the pulse travels, the less stiff your arteries are. They will also look at different types of blood pressure readings, changes in heart size, and other markers in the blood that can indicate stress on the body or problems with blood vessels.

Understanding if eplerenone can positively affect blood vessel stiffness and related health markers in kidney transplant patients is important. If successful, this research could pave the way for better treatments to protect the heart and blood vessels in people living with a new kidney, potentially improving their long-term health and quality of life after such a significant operation.

Key takeaways

This study is for people who have had a kidney transplant.
It tests a drug called eplerenone to see if it helps reduce blood vessel stiffness.
Participants will have regular check-ups including blood pressure and blood tests.
The study lasts about a year and involves taking medication.
You can stop participating at any time if you wish.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. Both men and women are welcome to participate. The study is specifically for people who have received a kidney transplant.

More detailed criteria about your specific health condition after transplant, other medications you might be taking, and your overall health will be discussed with the study team. They need to ensure the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently had a kidney transplant?
Are you able to attend regular hospital appointments?
Are you willing to take a study medication as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved for a period of about a year after your kidney transplant. You would receive the study medication, eplerenone, which is a tablet taken at 25 mg. This is a 'crossover' study, meaning you might take eplerenone for a period and then be switched to a neutral substance (a placebo) for another period, or vice versa, without knowing which you are taking at the time. This helps researchers compare the effects accurately.

You would have regular hospital visits for check-ups and assessments. These visits would involve measurements of your blood pressure and blood vessel stiffness using a device called a Sphygmocor. They would also include blood tests to check your kidney function, look for certain markers in your blood, and check for levels of potassium, as eplerenone can sometimes affect potassium levels. You might also have scans such as heart ultrasound and measurements of your neck arteries. All collected information and samples will help the researchers understand how the medicine is working and its overall effects on your health. You can expect follow-up appointments after the main treatment period to monitor your health.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from closer monitoring of your health, and the study drug, eplerenone, could potentially improve your blood vessel health. However, there's no guarantee of personal benefit, and the drug might not work for you. Potential risks include side effects from the medication, such as changes in your potassium levels, which will be regularly monitored, or other unexpected reactions. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is eplerenone?

Eplerenone is a medication that helps block certain hormones, which can affect blood pressure and heart health. It's also known by the brand name Inspra.

Why are blood vessels stiff after a kidney transplant?

Kidney disease and the transplant process can lead to changes in your body that make blood vessels less flexible. Stiff blood vessels can put extra strain on your heart.

What is a 'crossover' study?

In a crossover study, participants receive the study drug for a period and then switch to a placebo (a dummy pill) for another period, or vice-versa. This helps researchers compare the drug's effects more clearly.

Will I know if I'm getting the real drug or a placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving eplerenone or the placebo at any given time. This helps ensure fair results.

What is 'pulse wave velocity'?

Pulse wave velocity (PWV) is a measurement that tells doctors how quickly your pulse travels through your arteries. A faster speed can mean your arteries are stiffer.