NCT06291103View on ClinicalTrials.gov

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)

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

March 1, 2031

Study Completion Date

March 1, 2031

Conditions
Kidney Transplant Rejection
Interventions
DRUG

Conversion to Belatacep

CNI will be tapered within 3 months: 75 % of initial dose on the first month, 50 % on the second month, 25 % on the third month, and stopped and a conversion to Belatacept will be performed. It will be administered (6mg/kg) every 2W for the first 2 months and then every month until kidney graft survival.

DRUG

Standard of care treatment (SOC regimen) with Tacrolimus

Tacrolimus will be continued until kidney graft survival with objective of whole blood through levels between 6 and 8 ng/mL

All Listed Sponsors
lead

University Hospital, Rouen

OTHER

NCT06291103 - 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) | Biotech Hunter | Biotech Hunter