Pilot Phase 2 Study of Belatacept to Protect Kidney Function in Adult Heart Transplant Patients at Risk of Kidney Failure

What this Trial Is About

Researchers are evaluating the use of belatacept as a non-nephrotoxic immunosuppressive treatment for patients who have undergone heart transplantation and are at risk of chronic kidney disease CKD. CKD is a common complication after heart transplant and increases the risk of death and illness. The study is based on previous experience with belatacept in kidney transplantation, where it helped preserve kidney function but had some risk of rejection. This trial aims to see if belatacept combined with reduced use of calcineurin inhibitors can improve kidney function without increasing rejection risk in heart transplant patients. Participants will receive 9 injections of belatacept from 3 months to 12 months after their heart transplant, given monthly. The immunosuppressive treatment also includes induction with anti-lymphocyte serum and minimizing the use of calcineurin inhibitors, which are known to be harmful to the kidneys. This approach is being studied to see if it protects kidney function better than the usual treatments. During the study, participants will be monitored for kidney clearance at 12 months as the main outcome. Other assessments include heart tissue biopsies, antibody tests, blood glucose and hemoglobin A1C tests, death rates, and the number of dialysis sessions over 12 months. Participants will have regular visits for these tests and monitoring to track kidney health, heart rejection, and overall safety during the study period, which lasts up to one year.

Pilot Study: Interest of Belatacept as a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients at Risk of Chronic Renal Failure (BELACOEUR)