RecruitingNAINTERVENTIONAL

Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation

Kidney transplantation is a life-changing treatment for severe kidney disease. However, sometimes the body's immune system can reject the new kidney. Doctors already know some things that make rejection more likely, but they need better ways to predict it accurately, so they can give patients the best possible care. This study is researching a specific marker found on certain white blood cells (T-cells, specifically something called CD45RC). Previous research suggested that if a patient has a high amount of this marker before their kidney transplant, they might have a higher chance of their body rejecting the new kidney. This new study aims to check if this is true in a larger group of patients.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Angers

Enrolment target

150

Start

03 Feb 2021

Estimated completion

02 Feb 2026

End-stage Renal Disease

What is this study about?

When someone has serious kidney failure, a kidney transplant is often the best treatment. It can really improve their health and help them live longer. Even though doctors have gotten much better at preventing rejection, it still happens in a number of patients, especially in the first year after the transplant. When a body rejects a new kidney, it can cause problems and affect how long the new kidney lasts.

Doctors are always looking for better ways to predict who might be at higher risk of rejection. Knowing this ahead of time would help them give more personalised treatment to each patient. For example, they might be able to adjust medicines to prevent rejection more effectively. This study focuses on a specific marker on certain immune cells, called T-cells. These T-cells are important because they are involved in recognising and potentially rejecting the new kidney.

Previous research hinted that if a patient has a lot of a specific marker called CD45RC on their T-cells before their transplant, they might have a higher chance of their body rejecting the new kidney. This study is designed to carefully look at this idea again, with more patients. By doing this, we hope to confirm if this marker can indeed help predict rejection, which could lead to better ways to manage kidney transplants in the future. The goal is to make kidney transplants even more successful.

Key takeaways

This study is testing if a specific marker in your blood can predict kidney rejection.
It aims to improve care for future kidney transplant patients.
Participation involves giving blood samples; no new treatments.
You will receive standard kidney transplant care.
You can stop participating at any time without affecting your medical treatment.

Who may be eligible?

This study is looking for adults aged between 18 and 70 years old who are going to have their first kidney transplant (meaning they haven't had one before). To join, you should be considered at a low immunological risk, which means your body is not expected to be overly reactive to the new kidney.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, you wouldn't be eligible. Also, if you have difficulty understanding French, or if you are in a situation where you cannot freely decide whether to take part (for instance, if you are in prison or under certain legal protections), then you won't be able to join this particular study.

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 between 18 and 70 years old?
Are you having your very first kidney transplant?
Are you considered to have a low risk for immune reactions?
Do you understand the study information clearly (in English, given the request is for a UK audience)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

This study involves collecting blood samples. You won't be given any new medication or treatments as part of this research, beyond your standard care. The researchers will simply be analysing your blood to look at specific markers. The goal is to see if these markers can help predict the risk of your body rejecting the new kidney. Since this is an observational study, it will likely involve a series of blood tests over time, following you from before your transplant and for a number of years afterwards, to see how your body responds to the new kidney.

Potential risks and benefits

The main benefit of taking part in this study is contributing to valuable research that could lead to improved care for future kidney transplant patients. There are no direct medical benefits to you personally. The risks involved are generally low, mainly related to giving blood samples, such as minor bruising or discomfort. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Dr Anne-Sophie GARNIER
Verified postcode
Angers, France· Recruiting

Common questions

What is a 'biomarker'?

A biomarker is like a measurable sign in your body, such as in your blood, that can tell doctors something about your health or your risk of developing a condition. In this study, we're looking at a specific marker on your immune cells.

What is 'acute rejection'?

Acute rejection happens when your body's immune system suddenly recognises the new kidney as 'foreign' and tries to fight it off. This can harm the new kidney and is something doctors work hard to prevent.

Will I get any special treatment in this study?

No, you won't receive any special treatments or medications because of this study. You will continue to receive the standard care for kidney transplant patients. The study is purely observational, meaning we're just collecting information.

How many times will I need to give blood?

The study involves collecting blood samples over a period of time, starting before your transplant. The exact number of samples and timing will be fully explained by the study team if you are eligible and interested.

What will happen if I decide not to join the study?

If you decide not to join the study, or if you decide to leave at any point, it will not affect the medical care you receive for your kidney transplant in any way.

How to find out more

Anne-Sophie GARNIER, MD

annesophie.garnier@chu-angers.fr 0241356075 Official trial record

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