Active not recruitingOBSERVATIONAL

Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation

This study is investigating why people who have had a kidney transplant are more likely to develop problems with their blood vessels, such as atherosclerosis, which is a build-up of fatty plaques. Doctors know that traditional risk factors don't fully explain why this happens. They believe that the body's immune system, which usually fights off infections, might be involved. Researchers are particularly interested in a specific type of immune cell called 'regulatory T cells' and how they might influence the risk of these blood vessel complications after a transplant. The study involves taking blood samples from kidney transplant patients to learn more about how these immune cells behave.

At a glance

Status

Active not recruiting

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

1,150

Start

28 Nov 2008

Estimated completion

23 Oct 2030

What is this study about?

When you have a new kidney, your body's natural defence system, called the immune system, is very important. This study is exploring a common problem that can happen after a kidney transplant: the build-up of fatty deposits in your blood vessels, known as atherosclerosis. This can lead to serious health issues.

While we know that certain things like high blood pressure or cholesterol can cause atherosclerosis, these don't fully explain why it's more common in people with kidney transplants. Researchers think that the immune system, which is crucial in fighting off illnesses and keeping the body healthy, might play a big part in this. They are particularly interested in special immune cells called 'regulatory T cells' and how they might affect the risk of these blood vessel problems.

The main goal of this study is to understand these immune system processes better. By taking blood samples from transplant patients, researchers hope to discover how these cells work and if their levels are linked to developing complications. This knowledge could help doctors find new ways to prevent or treat these issues in the future, ultimately improving the health of people who have received kidney transplants.

Key takeaways

This study aims to understand why blood vessel problems are more common after kidney transplants.
It focuses on how your body's immune system, specifically 'regulatory T cells', might be involved.
Participation involves giving a blood sample, likely during a routine visit.
No new medicines or treatments are part of this study.
Your medical care will not be affected by taking part or choosing not to.
The research could lead to better ways to protect transplant patients' hearts and blood vessels.

Who may be eligible?

To join this study, you must be 18 years old or older and have received a kidney transplant. You also need to be able to understand what the study is about, including any potential benefits and risks, and be willing to give your written permission to take part.

There are certain reasons why you wouldn't be able to join. For example, if you have a medical condition that makes it hard to understand the study, or if you're currently being treated for cancer (some specific exceptions apply, like certain skin cancers or cancers that are completely cured). Also, if you have a severe active infection or serious liver disease, you wouldn't be able to participate.

Importantly, this study won't interfere with any other medical studies you might be part of or any treatments you're receiving. It's designed to be very simple and doesn't involve any new medicines or changes to your current care.

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 over 18 years old?
Have you had a kidney transplant?
Can you understand what the study involves and agree to take part?
Are you free from active cancer (with exceptions for some cured or skin cancers)?
Do you not have a severe active infection or serious liver problem?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the main thing you'll be asked to do is provide a blood sample. This blood sample will be taken during a regular check-up or appointment, so it won't require any extra visits. There are no special treatments, medications, or extra procedures involved. Your medical team will also keep track of your health over time, specifically looking for any blood vessel problems that might develop. This study is mainly about collecting information from your blood samples and your health records, not changing your care.

Potential risks and benefits

The main benefit of taking part is contributing to important research that could help future kidney transplant patients. By understanding more about how the immune system affects blood vessel health after a transplant, doctors might be able to develop better ways to prevent and treat these complications. The risks are very low, mainly just the usual small discomfort or bruising from a standard blood test. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (7)

CHU de Besançon
Verified postcode
Besançon, France
CHU Clermont-Ferrand, 58 rue Montalembert, 63003 Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France
CHU Dijon, Hôpital du Bocage, 2 Bd du Maréchal de Lattre de Tassigny, 21079 Dijon cedex
Verified postcode
Dijon, France
Hôpital du Kremlin Bicêtre 78, rue du Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex
Verified postcode
Le Kremlin-Bicêtre, France
CHU Brabois, et Vandoeuvre les Nancy
Verified postcode
Nancy, France
CHU Reims, 45 rue Cognacq-Jay 51092 Reims Cedex
Verified postcode
Reims, France
Hôpital Civil- 1, place de l'hôpital BP426 ; 67091 Strasbourg Cedex
Verified postcode
Strasbourg, France

Common questions

What is atherosclerosis?

Atherosclerosis is when fatty deposits, or plaques, build up in your arteries, making them narrow and hard. This can lead to serious heart and circulation problems.

What are 'regulatory T cells'?

These are a type of immune cell that helps to keep your immune system in balance and stop it from overreacting. Researchers are studying if they play a special role after a kidney transplant.

Will I have to take any new medicines?

No, this study does not involve taking any new medicines or changing your current treatment. It's purely an observational study.

How long will I be in the study?

The study involves collecting a blood sample and then tracking your health information over time. You won't have specific appointments just for the study, it works alongside your regular check-ups.

Will my doctors know if I join?

Yes, your medical team will be aware if you participate, and it will not affect the care you receive from them.