RecruitingOBSERVATIONAL

Tacrolimus Pharmacokinetic Subpopulations

This research is looking into how your body processes a crucial medicine called tacrolimus, which helps prevent your body from rejecting a new kidney after a transplant. We know that some people process this medicine differently, and this might affect how well their transplanted kidney works over time. This study aims to understand these differences better by looking at certain chemicals in your blood (called metabolites) that are made when your body breaks down tacrolimus. Doctors want to find out why some people process the medicine quickly and if this leads to any problems for their kidney. By understanding this, the hope is to be able to personalise tacrolimus treatment for each patient, potentially improving the long-term success of kidney transplants.

At a glance

Status

Recruiting

Sponsor

University Hospital, Grenoble

Enrolment target

180

Start

28 Jul 2020

Estimated completion

01 Aug 2027

Kidney Transplant Failure and Rejection Immunosuppression-related Infectious Disease

What is this study about?

When you have a kidney transplant, you need to take medicines to stop your body from rejecting the new kidney. One very important medicine is called tacrolimus. While tacrolimus is excellent at preventing rejection, it can also have side effects, and finding the right dose for each person is tricky. Doctors know that getting the dose just right is important, as too much can be harmful and too little might not protect your kidney enough.

This study is about understanding how your body deals with tacrolimus. We know that some people break down this medicine very quickly, and some do it more slowly. There's a thought that people who break it down very quickly might have different outcomes for their transplanted kidney. This research aims to look closely at these differences by measuring specific chemicals (called metabolites) that are created when your body processes tacrolimus.

The main goal of this study is to see if these different ways of processing tacrolimus affect how well your new kidney works over four years after your transplant. By learning more about this, and finding out what causes these differences in how people process the medicine, doctors hope to be able to give each patient the most effective and safest dose of tacrolimus. This could lead to more personalised treatment plans and ultimately help transplanted kidneys last longer.

Key takeaways

This study investigates how your body processes tacrolimus after a kidney transplant.
It aims to understand if different processing speeds affect your new kidney's health.
The goal is to help doctors personalise tacrolimus doses for better long-term outcomes.
Participation involves routine blood tests over four years, no new medicines.
Your contribution could improve future kidney transplant care for many.

Who may be eligible?

To join this study, you must be an adult (18 years or older) who has recently had a kidney transplant (no more than 7 days ago) at one of the participating hospitals (CHUGA, CHU Saint-Etienne, or CHU Clermont-Ferrand). You must be taking tacrolimus as part of your anti-rejection medication, along with other specific drugs, and there should be no plans to stop your tacrolimus treatment over the next four years.

You also need to be part of a social security scheme, be able to understand the study information, and provide your permission to take part, including for genetic tests. If you are a woman who could become pregnant, you must be using effective contraception.

However, you cannot join if you have a medical reason not to take tacrolimus, if you were already taking tacrolimus before your transplant, or if you are pregnant, breastfeeding, or have recently given birth. You also can't take part if you are in prison, under guardianship, or already involved in another study that would prevent you from joining this one.

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 an adult (18 or older) who just had a kidney transplant (within 7 days)?
Are you taking tacrolimus as part of your anti-rejection medicine?
Do you plan to stay on tacrolimus for at least four more years?
Are you generally able to give informed consent for studies and genetic tests?
If you are a woman who could get pregnant, are you using effective birth control?

Answer every question to see your result.

What does participation involve?

If you join this study, doctors will keep a close eye on your tacrolimus levels and other related chemicals in your blood over four years. This will involve regular blood tests during your routine check-ups after your kidney transplant. You will continue to take your tacrolimus and other anti-rejection medicines as prescribed by your transplant team. The study is particularly interested in tracking these levels and how they might relate to your kidney's health during this time. There aren't any extra clinic visits specifically for this study beyond your usual follow-up appointments.

Potential risks and benefits

The potential benefits of taking part in this study are that you would be contributing to valuable research that could help doctors understand how to better tailor tacrolimus treatment for future kidney transplant patients, potentially leading to better long-term kidney health for many. There are no direct personal medical benefits for you from taking part in this study beyond your standard care. The main risks involve the discomfort of regular blood tests, which are already part of your routine care after a transplant. All medical procedures have some risks, but these are generally very low for blood tests. You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (2)

Grenoble University Hospital
Verified postcode
Grenoble, France· Recruiting
Saint Etienne University Hospital
Verified postcode
Saint-Etienne, France· Not yet recruiting

Common questions

What is tacrolimus?

Tacrolimus is a powerful medicine given after a kidney transplant to stop your body from rejecting the new kidney.

What are 'metabolites'?

When your body breaks down a medicine like tacrolimus, it creates new chemicals called metabolites. Doctors want to measure these.

Does this study involve taking a new medicine?

No, you will continue to take your tacrolimus as prescribed. This study focuses on how your body handles it.

How long will I be in the study?

The study will look at information collected over the four years following your kidney transplant.

Will my treatment change during the study?

Your doctors will continue to manage your medication as they usually would to give you the best care. The study aims to gather information, not change your treatment.

How to find out more

Thomas JOUVE, MD, PhD

tjouve@chu-grenoble.fr +33476765460 Official trial record

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