Study of Temporary Use of Belatacept Instead of Calcineurin Inhibitors from 3 to 12 Months After Kidney Transplant in Adults with Early Graft Problems

What this Trial Is About

Researchers are evaluating a new treatment strategy for patients who have undergone kidney transplantation but experience early graft dysfunction. The study focuses on replacing the standard calcineurin inhibitors CNI, which can cause chronic kidney damage, with belatacept, a newer drug that affects the immune response differently. This Phase 3 trial aims to test if temporarily switching from CNI to belatacept between 3 and 12 months after transplant can improve kidney function without increasing rejection risks or costs. Participants will receive belatacept through intravenous infusions initially every two weeks and then monthly from 3 to 12 months post-transplant, while stopping CNI during this period. After 12 months, belatacept treatment will stop, and low-dose CNI will be reintroduced for the following 6 months. This two-phase approach will help researchers understand if this temporary replacement is feasible and beneficial compared to continuous CNI or belatacept use. During the study, patients will have regular kidney function tests, biopsies, immune system monitoring, and assessments of treatment tolerance and quality of life up to 15 months after transplant. Researchers will track rejection episodes, viral infections, and healthcare costs. The main goal is to see if kidney function remains stable after switching back to CNI. This detailed follow-up will help determine the practicality and economic impact of this new treatment approach.

Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction