Study on the Effects of Belatacept, Ciclosporin, and Tacrolimus on Blood Vessel Health in Kidney Transplant Patients

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What is this study about?

This clinical trial is focused on studying the effects of different treatments on patients who have undergone a kidney transplant. The study involves comparing the effects of a medication called Belatacept with a group of medications known as anticalcineurins, which include Ciclosporin and Tacrolimus. These medications are used to help manage the body’s immune response after a kidney transplant, which is crucial for the success of the transplant.

The purpose of the study is to see if switching from anticalcineurins to Belatacept can improve the function of blood vessels in kidney transplant patients over a period of six months. Blood vessels are important for carrying blood throughout the body, and their ability to widen and narrow properly is a sign of good health. The study will involve regular check-ups and tests to monitor the health of the blood vessels and overall well-being of the participants.

Participants in the study will be divided into two groups. One group will continue their current treatment with anticalcineurins, while the other group will switch to Belatacept. The study will last for several months, during which time participants will receive their assigned treatment and undergo various assessments to track changes in their blood vessel function. The results will help determine if Belatacept offers any advantages over anticalcineurins in maintaining healthy blood vessels in kidney transplant patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, kidney transplant history, and stable renal function.

Participants are divided into two groups: the Belatacept group and the anticalcineurin group.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes evaluating the dilation of arteries and other vascular functions using ultrasound and echotracking techniques.

3 medication administration

Participants in the Belatacept group receive the medication through IV infusion.

Participants in the anticalcineurin group continue their current oral medication, which may include ciclosporin or tacrolimus.

4 ongoing monitoring

Regular monitoring occurs over a 6-month period. This includes measuring changes in artery dilation, blood pressure, and other indicators of vascular health.

Blood tests are conducted to measure concentrations of specific substances related to vascular function.

5 final assessment

At the end of the 6-month period, a final assessment is performed. This includes repeating the initial tests to compare changes in vascular function.

The results are analyzed to determine the effects of Belatacept compared to anticalcineurins.

Who Can Join the Study?

For the Belatacept group: Patients who have had a kidney biopsy due to worsening kidney function and need to switch from anticalcineurins to Belatacept.
For the anticalcinurin group: Kidney transplant patients who have been on anticalcineurins for more than a year.
For the anticalcinurin group: Patients with stable kidney function, meaning their creatinine level (a waste product measured in the blood) has been steady for 3 months with only small changes.
For both groups: The kidney transplant must have been done more than 1 year ago.
For both groups: Patients must be between 18 and 75 years old.
For both groups: Patients must have received clear information about the study, read and understood the information letter, and signed the consent form.
For both groups: Women must use contraception and have a negative pregnancy test or have not had a menstrual period for 12 months.

Who Cannot Join the Study?

Patients who have had a kidney transplant 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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Rouen	Rouen	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Belatacept is a medication used in kidney transplant patients to help prevent the body from rejecting the new organ. It works by blocking certain signals in the immune system that can lead to organ rejection. In this trial, Belatacept is being studied to see if it can improve the function of blood vessels in kidney transplant patients.

Anticalcineurins are a group of medications commonly used to prevent organ rejection in transplant patients. They work by suppressing the immune system to stop it from attacking the transplanted organ. This trial is comparing the effects of Anticalcineurins with Belatacept to see which is more effective in improving blood vessel function in kidney transplant patients.

Kidney Transplant – A kidney transplant is a surgical procedure in which a healthy kidney from a donor is placed into a person whose kidneys no longer function properly. This condition arises when the kidneys are unable to filter waste from the blood effectively, leading to a buildup of harmful substances in the body. The transplanted kidney takes over the work of the failed kidneys, allowing the recipient to lead a more normal life. Over time, the body may attempt to reject the new kidney, which is why patients often require medications to suppress the immune response. The success of a kidney transplant can be influenced by various factors, including the match between donor and recipient and the recipient’s overall health. Regular monitoring and follow-up care are essential to ensure the transplanted kidney functions well.

Trial ID:

2024-515577-10-00

Protocol code:

2021/0391/HP

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Belatacept, Ciclosporin, and Tacrolimus on Blood Vessel Health in Kidney Transplant Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?