Study of Belatacept versus Tacrolimus in Kidney Transplant Recipients with Subclinical Antibody Mediated Rejection

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What is this study about?

This clinical trial focuses on patients who have undergone kidney transplantation and are experiencing a specific condition called subclinical antibody mediated rejection. This type of rejection occurs when the body produces antibodies against the transplanted kidney, even though there may not be obvious signs of the kidney not working properly. The study specifically looks at cases where these antibodies, called donor specific antibodies, develop after the transplant.

The study compares two different medications used to prevent rejection of the transplanted kidney. The first medication is belatacept, which is given through an intravenous injection, combined with standard treatment. The second medication is tacrolimus, which is taken as oral capsules, also combined with standard treatment. The purpose is to determine which medication works better in treating rejection when these new antibodies are detected.

The treatment period lasts for 12 months, during which patients will receive either belatacept or tacrolimus. Throughout the study, doctors will monitor how well the kidney is working by checking kidney function through blood tests and examining small samples of kidney tissue. They will also track the levels of antibodies in the blood and watch for any side effects of the medications.

1 Initial biopsy and diagnosis

A biopsy of your transplanted kidney will be performed to check for signs of rejection

The biopsy results will determine if you have subclinical antibody mediated rejection (sABMR), which means your body may be developing antibodies against your transplanted kidney without obvious symptoms

2 Treatment assignment

Based on your biopsy results, you will receive one of two medication combinations:

Option 1: Belatacept (Nulojix) given by intravenous injection, combined with standard care medications

Option 2: Tacrolimus (Advagraf) taken as oral capsules, combined with standard care medications

3 12-month follow-up period

Regular monitoring of your kidney function through blood and urine tests

Doctors will check your creatinine levels and calculate how well your kidney is filtering (eGFR)

Your urine will be tested for protein levels

Blood tests will check for viral infections (BK virus, CMV, and EBV)

After 12 months, another kidney biopsy will be performed to check your kidney’s condition

4 Extended monitoring

Your kidney function will continue to be monitored up to 36 months

Regular blood and urine tests will continue

Your medical records will be reviewed to track any complications or hospitalizations

The presence of antibodies against your transplanted kidney will be monitored through blood tests

Who Can Join the Study?

  • Must be a person who has received a kidney transplant
  • Must be an adult (18 years or older)
  • Must have developed new antibodies against the donor kidney (de novo DSA) that:
    – Were not present on the day of transplantation
    – Were not present in blood tests before transplantation
    – Show specific measurements on laboratory tests (MFI greater than 1000 on special blood tests)
  • Must have stable kidney function when these new antibodies are detected:
    – Kidney function test (eGFR) should not vary more than 20% compared to the previous 3 months
    – Protein in urine test must show less than 0.5 grams of protein per gram of creatinine
  • Must have evidence of early rejection in kidney biopsy (active sABMR) with minimal damage to kidney structures (classified as very slight transplant glomerulopathy)
  • Can be either male or female

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Patients who have not undergone a kidney transplant
  • Patients without donor specific antibodies (proteins that can attack the transplanted kidney)
  • Patients who do not have subclinical antibody mediated rejection (early stage of transplant rejection without visible symptoms)
  • Patients who cannot take belatacept or tacrolimus (anti-rejection medications)
  • Patients who are pregnant or breastfeeding
  • Patients with severe infections or active diseases that could interfere with the study medications
  • Patients participating in other clinical trials
  • Patients unable to provide informed consent
  • Patients with known allergies to study medications
  • Patients with significant liver disease or abnormal liver function
  • Patients with uncontrolled diabetes
  • Patients with active cancer or history of cancer in the past 5 years

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Pellegrin Hospital Bordeaux France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hopital Huriez Lille France
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Cshkpj Hxbettigdqf Raljkgwn Ujwxukayjlsig Dq Tgbts Tours France
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Hxaqzqqb Ujojwgvqogpveu Ssqgrybyak &ussvwl Hlrhpmc dx Hdesvonadcd STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.07.2025

Trial locations

Investigated drugs:

Belatacept is a medication that helps prevent organ rejection in kidney transplant patients. It works by suppressing the immune system to reduce the risk of the body attacking the transplanted kidney. It is specifically used to treat patients who have developed antibodies against their donor kidney, even when they don’t show obvious symptoms of rejection.

Tacrolimus is a commonly used anti-rejection medication that also works by suppressing the immune system. It helps prevent the body from rejecting the transplanted kidney by controlling the immune system’s response. It is considered a standard treatment option for kidney transplant recipients and is often used in combination with other medications to prevent organ rejection.

Both medications are used as part of a standard care regimen for kidney transplant patients who show signs of developing antibodies against their donor organ, even before obvious rejection symptoms appear.

Investigated diseases:

Kidney Transplant Rejection – A condition where the recipient’s immune system recognizes the transplanted kidney as foreign and attacks it. The process can develop slowly over time (chronic rejection) or occur rapidly (acute rejection). The immune system creates antibodies against the donor kidney, leading to inflammation and potential damage to the transplanted organ. This condition can cause the transplanted kidney to function less effectively over time. The body produces specific antibodies called donor-specific antibodies (DSA) that target the transplanted kidney’s tissues.

Antibody-Mediated Rejection (ABMR) – A specific type of transplant rejection where antibodies produced by the recipient’s immune system attack the blood vessels of the transplanted kidney. This condition can develop without immediate symptoms (subclinical ABMR) or with clear clinical signs. The process involves the formation of antibodies that specifically target the donor organ’s tissues. These antibodies can cause inflammation and damage to the blood vessels within the transplanted kidney.

Trial ID:
2024-516527-13-00
Protocol code:
2022/0342/HP
Trial Phase:
Human Pharmacology (Phase I) – Other

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