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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Randomized controlled trial evaluating the impact of mineralocorticoid receptor blockade by eplerenone on echocardiographic abnormalities among kidney graft recipient under calcineurin inhibitors. KT-CANOPY: Cardiac improvement by eplerenone among patients under cyclosporine or tacrolimus for kidney transplantation.

This study, called KT-CANOPY, is for individuals who have received a kidney transplant. We're investigating whether a medication called eplerenone can help improve heart health. People who've had kidney transplants often take other drugs (like cyclosporine or tacrolimus) that can sometimes affect the heart. We want to see if eplerenone can reduce the risk of serious heart problems, such as heart failure or heart attacks. We'll also be looking closely at how the medicine affects the size and pumping ability of the heart over approximately 36 weeks. The goal is to find better ways to protect the hearts of kidney transplant patients.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
CHRU De Nancy
Enrolment target
132
Start
07 Mar 2025

What is this study about?

If you've had a kidney transplant, your doctors focus on keeping your new kidney healthy. However, some medications you take to stop your body from rejecting the new kidney, such as cyclosporine or tacrolimus, can sometimes have effects on your heart over time. This can include changes to the size and function of your heart, and potentially increase the risk of heart-related issues.

This study, named KT-CANOPY, is designed to see if a specific medication called eplerenone can help protect the hearts of people who have received a kidney transplant. Eplerenone works by blocking certain hormones that can affect the heart and blood vessels. We want to find out if taking eplerenone can reduce the chances of developing serious heart problems like heart failure or even a heart attack.

Our main focus is to see if eplerenone can improve key heart measurements, specifically how the main pumping chamber of the heart changes in thickness, and also how the upper chamber changes in size. We'll be carefully comparing people who take eplerenone with those who don't, to understand its effects. By doing this research, we hope to discover better ways to care for the hearts of kidney transplant patients and help them live healthier lives.

Key takeaways

  • Tests if eplerenone can improve heart health in kidney transplant patients.
  • Compares eplerenone to a dummy pill over 36 weeks.
  • Will monitor heart size and function with scans and blood tests.
  • Aims to reduce serious heart problems like heart failure or heart attacks.
  • For adults aged 18 and over who have had a kidney transplant.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults who have had a kidney transplant. Both men and women are welcome to take part. There is no upper age limit for participants, so anyone aged 18 or over can be considered.

To be eligible, you will likely need to be taking specific medications for your kidney transplant, which your doctor will be able to clarify. The research team will review your medical history and current health to make sure the study is a safe and suitable option 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.

  1. Are you 18 years old or older?
  2. Have you had a kidney transplant?
  3. Are you currently taking medications like cyclosporine or tacrolimus for your transplant?
  4. Are you comfortable with regular hospital visits and health checks?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to either receive the study medication (eplerenone) or a placebo (a dummy pill) for about 36 weeks. This means neither you nor your doctor would know which one you are taking. You would have several visits over this period for health checks.

At these visits, the study team would perform heart scans (like an echocardiogram) to measure your heart's size and function. They would also take blood and urine samples to check your kidney function, blood pressure, and other markers of heart health. You would discuss any changes in your health or medications with the study team at each visit. The total duration of your participation would be around 36 weeks.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, but it could help us learn more about preventing heart problems in kidney transplant patients. Like all medications, eplerenone has potential side effects, which the study team will discuss with you. These might include changes in your blood salt levels, especially potassium, which will be monitored closely. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What is eplerenone?

Eplerenone is a medication that helps block certain hormones. In this study, we're looking to see if it can protect the heart in people who have had a kidney transplant.

Why is this study important for kidney transplant patients?

Kidney transplant patients sometimes face heart problems due to their health or medications. This study aims to find out if eplerenone can help keep their hearts healthier.

What does a 'randomised controlled trial' mean?

It means participants are randomly put into groups – one gets the study drug, and the other gets a dummy pill (placebo). This helps us fairly compare the effects of the drug.

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

No, during the study, neither you nor your doctor will know if you're taking eplerenone or the placebo. This helps ensure fair and unbiased results.

How long will I be involved in the study?

If you join, your participation will last for about 36 weeks, which is roughly 8 to 9 months.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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