Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R)

Launched by UNIVERSITY HOSPITAL, ROUEN · Feb 26, 2024

Keywords

ClinConnect Summary

The BELA-M-R trial is studying a condition called antibody-mediated rejection (ABMR) in kidney transplant patients, particularly focusing on a specific type known as subclinical ABMR (sABMR). This condition can cause problems in the transplanted kidney without noticeable symptoms. The trial aims to evaluate whether a new treatment approach using a medication called belatacept, along with standard care, can improve outcomes for patients who develop new donor-specific antibodies (DSAs) after their transplant. This is important because early detection and treatment of sABMR may help protect the kidney and prevent further complications.

To participate in the study, you must be an adult who has received a kidney transplant and have developed these new DSAs without any signs of kidney problems. Participants will receive either the new treatment or continue with their current medication. The trial will also help researchers understand how common sABMR is in kidney transplant recipients. If you’re interested in participating or want to know more, it's important to discuss this with your healthcare team to see if you meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Screening inclusion criteria:
• • 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)
• • Affiliation with, or beneficiary of a Social security (national health insurance) category
• • Person having read and understood the information letter and signed the consent form
• • Women of childbearing potential with effective contraception/very-effective contraception (Cf. CTFG) (oestro-progestatives or intra-uterine device or tubal ligation) and a negative blood pregnancy test.
• • Women surgically sterile (absence of ovaries and/or uterus)
• • Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
• 2. Randomization inclusion criteria:
• • Patients with active sABMR, according Banff 2019 classification, with very slight transplant glomerulogathy (cg = 0 or 1).
• Exclusion Criteria:
• 1. Screening exclusion criteria:
• • Minor
• • Specific treatment for DSA occurrence before kidney graft biopsy: IVIG or rituximab or plasmapheresis or immunoabsorption
• • ABO incompatible kidney transplantation
• • Combined transplantation
• • Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.
• • Hypersensitivity to the active substance or to any of the excipients - Pregnant or parturient or breastfeeding woman or absence of contraception
• • Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision
• • Person consenting to the research participating to another trial
• • Medical history or psychological or sensorial abnormality prone to inhibit the subject to understand the conditions required for his/her participation to the protocol or unable him/her to give an informed consent
• • No signed ICF
• 2. Randomization exclusion criteria:
• • No sABMR or chronic active sABMR (cg \> 1) on initial biopsy
• • History of severe opportunistic infection before randomization
• • Acute or chronic infection with HBV, HCV or HIV
• • EBV negative serology
• • History of post-transplant lymphoproliferative disorder.