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Screening for subclinical antibody mediated rejection and efficacy of belatacept in the context of de novo donor specific antibody after kidney transplantation / BEL-AMR
EU CTIS ID: 2024-516527-13-00
What this study is testing
To demonstrate, at 12 months post-biopsy, the efficacy of belatacept combined with standard of care, compared to Tacrolimus combined with standard of care, among kidney transplant recipients with active subclinical antibody mediated rejection (sABMR) detected on initial biopsy to diagnose subclinical de novo donor specific antibodies (dnDSA).
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Kidney transplant recipient
- Adult
- De novo DSA (MFI > 1000 using the Luminex single antigen beads assay or positive with the manufacturer criteria according to the Luminex assay) absent on the day of kidney transplantation and in the sera prior to kidney transplantation
- No clinical graft dysfunction at time of DSA detection (< 20 % variation of eGFR compared to last 3 months before detection and < 0,5 g/g proteinuria/creatinuria ratio)
- Randomization inclusion criteria: - Patients with active sABMR, according Banff 2019 classification, with very slight transplant glomerulogathy (cg = 0 or 1).
You likely can't join if
- Specific treatment for DSA occurrence before kidney graft biopsy: IVIG or rituximab or plasmapheresis or immunoabsorption
- ABO incompatible kidney transplantation
- Combined transplantation
- Randomization exclusion criteria: No sABMR or chronic active sABMR (cg > 1) on biopsy Contraindication to Tacrolimus marketed as capsule or tablet pharmaceutical form o Hypersensitivity to tacrolimus or other macrolides o Hypersensitivity to any of the excipients Contraindication to NULOJIX 250 mg powder for concentrate for solution for infusion: o Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown. o Hypersensitivity to the active substance or to any of the excipients History of severe opportunistic infection before randomization History of infection with HBV, HCV or HIV EBV negative serology History of post-transplant lymphoproliferative disorder.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.