Study Comparing Belatacept-Based and Calcineurin Inhibitor-Based Treatments in Adolescents Aged 12 to 17 with Kidney Transplants

What this Trial Is About

Researchers are evaluating the benefits and risks of switching adolescent kidney transplant recipients aged 12 to less than 18 years from a calcineurin inhibitor-based immunosuppressive treatment to a belatacept-based regimen. This study aims to compare these two treatment approaches and assess how well patients adhere to their immunosuppressive medications. The trial is a phase 3, randomized study focusing on treatment outcomes for young kidney allograft recipients. Participants are assigned to one of two groups one group will convert from their current calcineurin inhibitor CNI treatment to belatacept, with a tapering and discontinuation of CNI, while the other group will continue their existing CNI-based regimen. The treatments involve specified dosing schedules of belatacept and other immunosuppressive drugs such as tacrolimus, cyclosporine A, mycophenolate mofetil, enteric-coated mycophenolate sodium, and corticosteroids. The study follows participants over a period of 24 months after randomization. Throughout the study, participants will be monitored for kidney function, graft survival, acute rejection episodes, adherence to medication regimens, and safety measures including lab tests and blood pressure. Researchers will collect data on estimated glomerular filtration rate eGFR, proteinuria, immunogenicity, and adverse events at multiple time points up to 24 months. This comprehensive monitoring helps evaluate the long-term effects and tolerability of switching to belatacept in adolescent kidney transplant recipients.

A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications