Study of Biomarker-Guided Calcineurin Inhibitor Replacement with Abatacept in Adult Kidney Transplant Recipients

What this Trial Is About

Researchers are studying adult first-time kidney transplant recipients to evaluate the Human Leukocyte Antigen HLA-DRDQ molecular mismatch mMM score as a biomarker for predicting post-transplant immune risk. The study includes an observational phase and a nested randomized controlled trial RCT to assess whether switching from Tacrolimus to abatacept improves kidney function and other health outcomes while maintaining rejection prevention. The study enrolls 800 adults in the observational phase to track HLA-DRDQ mMM scores and monitor immune events over 24 months. At six months post-transplant, about 300 eligible participants without rejection or infection and meeting immune criteria will be randomized to either abatacept with a tapering of Tacrolimus or standard care with continued Tacrolimus. The abatacept group receives weekly injections of 125 mg for 18 months, with close monitoring. Participants will be followed closely with biopsies, kidney function tests, neurocognitive assessments, and patient-reported outcome measures for up to 24 months. Safety and efficacy will be monitored, including tracking any acute rejection events. Those experiencing rejection will have samples collected for analysis. The research aims to validate the biomarker and assess treatment effects on kidney and cognitive health, along with quality of life.

Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation