Using belatacept instead of CNIs for kidney transplant patients with early graft dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of belatacept, a fusion protein that blocks CD28 costimulation, as a replacement for calcineurin inhibitors (CNI) in patients experiencing early graft dysfunction after kidney transplantation. The study aims to evaluate the safety and efficacy of belatacept administered 3 to 12 months post-transplantation, focusing on improving renal function and reducing chronic graft dysfunction associated with CNI nephrotoxicity. Participants will receive belatacept intravenously, and their renal function will be monitored through creatinine clearance assessments. The trial seeks to provide a viable alternative to standard CNI therapy, which has been linked to long-term graft failure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* adult older than 18 years old.
* transplantation of a deceased or living donor kidney (non-human leukocyte antigen(HLA)-identical) with blood type (ABO) compatibility
* no contraindication to the protocol graft biopsy (10 weeks post transplant)
* treatment by CNI / MPA +/- prednisone
* renal function estimated by creatinine clearance according to CKD-EPI \<30 ml / min / 1.73m2.
* having no difficulty in understanding and communicating with the investigator and his representatives.
* Agreeing to give informed written consent
* benefiting from a Social Security policy.
* results of the 10-week post-transplant renal biopsy finding no rejection or BK virus (member of the polyomavirus family) nephropathy, no recurrence, no thrombotic microangiopathy, no cortical necrosis.
* Seropositivity for Epstein-Barr virus (EBV)
* negative pregnancy test and agreement on the use of effective contraception throughout the study

Exclusion Criteria:

* Presence of Donor Specific Antibody during kidney transplant or appeared at 3 months post-transplantation.
* seropositivity for HIV
* another history of other solid organ transplants (outside the kidney)
* primary non-function (persistence of a need for dialysis at 3 months post-transplantation)
* participation in progress to another interventional clinical study
* any clinical condition that the investigator considers incompatible with the course of the study.
* contraindication to belatacept and Tacrolimus
* Pregnant or breastfeeding woman
* Inability of the patient to comply with study procedures
* Person placed under guardianship or curatorship, under safeguard of justice

Where it's running

• CHU Nantes
  Nantes, Loire Atlantique, France Recruiting

Study contacts

• Study coordinator: Simon VILLE, PH
• Email: simon.ville@chu-nantes.fr
• Phone: 0240087453

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.