Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Evaluation of the effect of tacrolimus on carbohydrate metabolism in pre-renal transplantation dialysis patients

This research is investigating a medicine called tacrolimus. Tacrolimus is often given to people after a kidney transplant to help prevent their body from rejecting the new kidney. However, this study focuses on people who are currently on dialysis for kidney failure, *before* they have a transplant. The main goal is to understand if taking tacrolimus for a short period (14 days) causes any changes in their blood sugar levels. Keeping blood sugar stable is important for overall health, especially for people with kidney conditions. By looking at these changes, doctors can better understand how to manage care for patients who may need tacrolimus.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Departemental Vendee

Enrolment target

Start

12 Jun 2024

Hemodialysis

What is this study about?

This study is about a medicine called tacrolimus. Doctors often give tacrolimus to people who have had an organ transplant, like a kidney transplant. It helps stop the body's immune system from 'attacking' and rejecting the new organ. However, this research is looking at people who have kidney failure and are on dialysis, *before* they receive a kidney transplant.

The main thing the researchers want to find out is whether taking tacrolimus for a short time (about two weeks) changes a person's blood sugar levels. Blood sugar, also known as blood glucose, is important because it's how your body gets energy. Levels that are too high or too low can cause health problems.

By understanding how tacrolimus affects blood sugar in people on dialysis, doctors can be better prepared to manage their patients' health. This information can help them decide the best way to use this medicine and watch out for any potential effects, making sure patients get the safest and most effective care possible as they prepare for a possible kidney transplant.

Key takeaways

The study looks at tacrolimus medicine in people on kidney dialysis.
It aims to see how tacrolimus affects blood sugar levels over 14 days.
Participants must be 18 or older and currently on hemodialysis.
Taking part helps improve understanding for future kidney patients.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part.

Both men and women can participate in this research. The study is specifically for people who have kidney failure and are receiving treatment called hemodialysis.

If you are currently on hemodialysis and meet the age requirements, you might be able to take part. The researchers will check other details to make sure the study is right for you.

Quick self-check

Am I 18 years old or older?
Am I currently receiving hemodialysis for kidney failure?
Have I discussed this study with my doctor?
Am I willing to have my blood sugar levels checked at the start and after 14 days?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive the medicine called tacrolimus. The study would look at your blood sugar levels before you start taking the medicine and again after 14 days of treatment. This would likely involve blood tests at the beginning and end of this short period.

You would visit the hospital or clinic at least twice for these assessments. The total duration of your active participation, including taking the medicine and having your blood sugar checked, would be around two weeks. Beyond this, there might be some follow-up, but the main part of the study is concentrated over these 14 days.

Potential risks and benefits

Taking part in this study may help doctors better understand how tacrolimus affects blood sugar in people with kidney conditions, which could improve care for future patients. However, taking any medicine, including tacrolimus, can have side effects. You might experience changes in your blood sugar levels, or other side effects associated with the medication. The research team will discuss all potential risks with you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What is hemodialysis?

Hemodialysis is a treatment for kidney failure where a machine filters your blood to remove waste products and extra fluid, taking over the job of your kidneys.

What is tacrolimus?

Tacrolimus is a medicine often used after organ transplants to help stop your body's immune system from rejecting the new organ.

Why are blood sugar levels important?

Keeping blood sugar levels balanced is important for your overall health, as levels that are too high or too low can cause various health problems.

Will this study help me directly?

While the main goal is to learn more for future patients, doctors will be closely monitoring your health during the study. Any direct benefits would be discussed with you by the care team.

How long will I be in the study?

The main part of the study, involving taking the medicine and having your blood sugar checked, will last about 14 days.