RecruitingOBSERVATIONAL

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

This study is investigating if the tiny germs living in our gut and blood, called the microbiota, can predict whether a person who has had a kidney transplant might reject their new kidney. We are focusing on patients who are taking a specific anti-rejection medicine called Nulojix. Researchers will look at samples taken from patients at the time of their transplant and over the first year afterwards. By understanding these tiny germs and how they relate to the body's immune system, we hope to find an 'early warning' sign for rejection. This could help doctors to better manage kidney transplants and improve the long-term health of patients.

At a glance

Status

Recruiting

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrolment target

Start

07 Oct 2021

Estimated completion

07 Jan 2027

Kidney Transplant Rejection

What is this study about?

When you have a kidney transplant, your body's immune system naturally tries to fight off the new organ because it sees it as foreign. Medicines are given to stop this 'rejection'. This study is looking at a specific medicine called Nulojix, which helps prevent rejection. Researchers want to understand if the types of tiny germs (microbiota) living in your tummy (gut) and circulating in your blood could play a role in whether your body accepts or rejects the new kidney.

Imagine your body's immune system has a complex balancing act to perform after a transplant. We know that the types of germs in and on our bodies can influence our immune system. This study will collect samples, like blood and stool (poo), from patients at the time of their transplant and regularly over the first year. They will look closely at the different types of bacteria in these samples. They will also examine certain immune cells within your blood.

The main goal is to see if there's a particular 'pattern' or specific type of germ that appears more often in patients who experience rejection. If such a pattern is found, it could one day help doctors identify patients at higher risk of rejection earlier. This might allow for more personalised care, potentially leading to better outcomes for people with kidney transplants.

Key takeaways

Researchers are studying gut and blood germs in kidney transplant patients.
The goal is to find early signs of transplant rejection.
The study focuses on patients receiving the anti-rejection medicine Nulojix.
Participation involves giving blood and stool samples over a year.
Findings could lead to better care for future transplant patients.

Who may be eligible?

This study is looking for people who are about to receive a kidney transplant. You must be between 18 and 70 years old. An important requirement is that you'll be receiving a specific set of medications after your transplant: induction therapy with Simulect, and then ongoing anti-rejection medicines called Nulojix, mycophenolate acid, and steroids. Before joining, you'll need to understand and sign a consent form, showing you agree to take part.

There are some reasons why you wouldn't be able to join. For instance, if you're receiving more than one organ transplant at the same time, or if you've had a transplant before. You also can't take part if you're receiving a different type of initial anti-rejection medicine called 'polyclonal antibodies'.

You also won't be able to join if you have certain infections like HIV, active hepatitis B or C, or any active bacterial infection. Pregnant or breastfeeding women cannot participate. Lastly, if for any reason you're unable to clearly understand or give your consent, you wouldn't be eligible for this 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 scheduled for a kidney transplant soon?
Will your doctors be giving you Simulect, Nulojix, mycophenolate acid, and steroids after your transplant?
Do you feel able to understand and sign a consent form for the study?
Are you free from conditions like HIV, active hepatitis, or other active bacterial infections?
Are you currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, the research team will collect samples from you at several points. This will include blood tests and stool (poo) samples. The first samples will be taken when you have your kidney transplant. After that, samples will be collected at various times throughout your first year after the transplant. You will also have your immune cells checked from blood samples. The study will last for a year after your transplant to observe how these factors change over time and relate to your health. You will continue to have your regular medical appointments and receive all your standard care for your kidney transplant.

Potential risks and benefits

Taking part in this study might not offer direct health benefits to you personally, but the information gained could greatly help future kidney transplant patients. The main risks involve the procedures for collecting samples, such as discomfort or bruising from blood draws. There's also a small chance of infection from any medical procedure. You will be taking standard anti-rejection medicines, and the study doesn't change that. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (9)

Nephrologie transplantation CHRU Besançon
Verified postcode
Besançon, France· Recruiting
Néphrologie, hémodialyse, aphérèses, transplantation rénale
Verified postcode
La Tronche, France· Recruiting
Nephrologie transplantation CHRU Nantes
Verified postcode
Nantes, France· Recruiting
Nephrologie transplantation CHU Saint Louis Paris
Verified postcode
Paris, France· Recruiting
Nephrologie transplantation CHU Pitié Salpetriere Paris
Verified postcode
Paris, France· Recruiting
Nephrologie hôpital Henri-Mondor
Verified postcode
Paris, France· Recruiting
Nephrologie transplantation CHRU Poitiers
Verified postcode
Poitiers, France· Recruiting
Nephrologie transplantation CHRU Toulouse
Verified postcode
Toulouse, France· Recruiting
Nephrologie transplantation CHRU Tours
Verified postcode
Tours, France· Recruiting

Common questions

What is 'microbiota'?

Microbiota refers to the trillions of tiny germs, like bacteria, that live in and on your body, especially in your gut. They play an important role in your health.

What is 'renal graft rejection'?

This is when the body's immune system sees a transplanted kidney (graft) as foreign and tries to attack it. Medicines are given to prevent this.

What is Nulojix?

Nulojix (Belatacept) is a specific medicine given to kidney transplant patients to help stop their immune system from rejecting the new kidney.

Will I get different medication if I join the study?

No, you will receive the standard anti-rejection medications as planned for your kidney transplant. This study simply observes and collects information about your existing treatment.

How long will I be involved in the study?

Your involvement in the study will last for approximately one year after your kidney transplant, during which samples will be collected periodically.

How to find out more

Antoine Durrbach, MD-PhD

antoine.durrbach@inserm.fr +33614112981 Official trial record

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