RecruitingPHASE3INTERVENTIONAL

Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction

This study is for adults in the UK who have had a kidney transplant and whose new kidney isn't working as well as it could be, three months after the operation. Usually, people take strong medicines called calcineurin inhibitors (CNIs) to stop their body from rejecting the new kidney. However, these drugs can sometimes harm the kidney long-term. Researchers want to see if switching from these standard drugs to a different medicine called belatacept, for a period of nine months (from 3 to 12 months post-transplant), can help the kidney work better without increasing the risk of rejection. The study will also look at whether this approach is practical and cost-effective for the healthcare system.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Nantes University Hospital

Enrolment target

Start

03 May 2024

Estimated completion

03 May 2027

Chronic Kidney Failure

What is this study about?

When you receive a new kidney, your body's immune system naturally tries to attack it, seeing it as foreign. To prevent this, doctors give you medicines called immunosuppressants. A common type of these drugs, called calcineurin inhibitors (CNIs), has been very effective at stopping rejection, allowing kidney transplants to become a much safer procedure.

However, while CNIs are good at preventing immediate rejection, they can sometimes cause problems for the kidney over many years, potentially leading to the kidney not working as well as it should. This can sometimes mean people need to go back on dialysis or even get another transplant. Scientists are always looking for ways to get the benefits of preventing rejection without these long-term side effects.

This study is focusing on a specific group of transplant patients: those whose new kidney isn't functioning at its best around three months after the transplant. For these patients, doctors want to see if they can temporary switch from CNIs to a newer drug called belatacept. Belatacept works differently to prevent rejection and has shown promise in improving kidney function in some studies. The idea is that using belatacept for a few months (from 3 to 12 months after transplant) could give the kidney a chance to recover and improve its function, and the study will assess if this temporary switch is better for the patient and if it's a good approach overall.

Key takeaways

A study for kidney transplant patients whose new kidney isn't working perfectly at 3 months.
Testing if a new drug, belatacept, can temporarily replace standard anti-rejection drugs.
Aims to improve long-term kidney function and reduce side effects of current medications.
Belatacept is given by intravenous drip for about 9 months.
This research could lead to better ways to manage kidney transplant patients.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

This study is looking for adult kidney transplant patients aged 18 to 99 years old. You must have received your new kidney from either a deceased or living donor, and your blood type must match. Importantly, your new kidney must not be working as well as expected three months after your transplant, as measured by a specific kidney function test. You also must be taking standard anti-rejection medication (CNIs) before joining.

To be considered, you'll need to have had a transplant at least 10 weeks before joining the study, and a recent kidney biopsy must show no signs of rejection, certain viral infections, or other specific kidney problems. You should also be positive for the Epstein-Barr virus (EBV), as this is important for how belatacept works. Women must not be pregnant or breastfeeding and must agree to use effective contraception if they are able to become pregnant.

There are also reasons why you might not be able to join. For example, if your body already has certain antibodies (called Donor Specific Antibodies) that target the new kidney, or if you have HIV, you won't be eligible. You also can't have received other organ transplants besides your kidney, still need dialysis at three months post-transplant, or be participating in another clinical 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 an adult (18-99 years old) who has had a kidney transplant?
Is your kidney function not ideal around 3 months after your transplant?
Are you currently taking calcineurin inhibitor (CNI) drugs?
Did you have a kidney biopsy around 10 weeks post-transplant with good results (no rejection or specific infections)?
Are you positive for the Epstein-Barr virus (EBV)?
Are you not pregnant or breastfeeding, and willing to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would switch from your current CNI medication to belatacept, which is given by a drip into your arm (intravenous infusion). This change would happen around 3 months after your transplant and would last for about 9 months, until you are 12 months post-transplant. During this time, you would have regular hospital visits for the belatacept infusions and to have blood tests and other checks to see how your kidney is working and to monitor for any side effects. After the 9-month period on belatacept, you would typically switch back to a CNI-based treatment, and doctors would continue to follow your health and kidney function for an extended period, which will be fully explained to you.

Potential risks and benefits

Participating in this study might offer you the potential benefit of improved kidney function and fewer long-term side effects from traditional anti-rejection drugs. However, there's always a risk with any new treatment or change in medication. Belatacept could have different side effects than your current treatment, and there's a chance your body might react differently to the change. Your doctors will carefully monitor you throughout the study to manage any risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU Nantes
Verified postcode
Nantes, France· Recruiting

Common questions

What is belatacept?

Belatacept is a medicine that helps prevent your body from rejecting a new kidney. It works by blocking certain signals in your immune system, different from traditional anti-rejection drugs.

Why switch from my current medication?

The study is exploring if switching from your current drugs (CNIs) to belatacept for a few months can help your kidney work better in the long run, as CNIs can sometimes cause kidney damage over time.

How is belatacept given?

Belatacept is given as a drip into a vein, which means you'll need to attend regular clinic visits for your treatment.

What if my kidney function improves?

The goal is to improve kidney function. If it does, the study will help us understand if this temporary switch is a good strategy for other patients in similar situations.

What happens after the study period on belatacept?

After about nine months on belatacept, you would typically switch back to your original type of anti-rejection medication, and your health would continue to be monitored by your transplant team.

How to find out more

Simon VILLE, PH

simon.ville@chu-nantes.fr 0240087453 Official trial record

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