Study Comparing Immunosuppressive Treatments After Kidney Transplant in Children and Young Adults Aged 13 to 20

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two different immunosuppressive drug regimens in children and young adults who have received a kidney transplant. This pediatric study focuses on comparing a treatment combining belatacept and sirolimus with a standard regimen of tacrolimus and Mycophenolate Mofetil MMF. The trial aims to improve transplant outcomes and is sponsored by the National Institute of Allergy and Infectious Diseases NIAID. Participants will be randomly assigned within 24 hours after their transplant to one of two groups. One group will receive antithymocyte globulin ATG, a steroid taper, belatacept infusions, a short tacrolimus bridge, and then switch to sirolimus around one month after transplant. The other group will receive ATG, a steroid taper, tacrolimus, and MMF. Belatacept is given intravenously on a scheduled timeline up to 24 months, and sirolimus dosing depends on participant weight. During the 12 to 24 months of follow-up, participants will have regular assessments including blood tests for donor-specific antibodies and kidney function, as well as biopsies to detect graft rejection and infections. Researchers will monitor adverse events and track outcomes such as infection rates and transplant complications. The study includes detailed lab monitoring and aims to measure the incidence of transplant-related complications up to 96 weeks post-transplant.

Advancing Transplantation Outcomes in Children