A Multi-centre, Open, Prospective, Randomized, Parallel-group, 24-month Study to Compare Continued Immunosuppression Versus Stopping at 6 Months to Prevent HLA Sensitization in Late Renal Graft Failure

What this Trial Is About

This research aims to compare the level of human leukocyte antigen (HLA) sensitization after two years in patients who have experienced late failure of their kidney transplant (lasting more than three months). The study evaluates whether continuing low-dose immunosuppressant treatment can safely reduce the risk of HLA sensitization compared to stopping immunosuppression at six months. It is a phase 4, open, randomized trial sponsored by the Hospital Universitari Vall d'Hebron Research Institute. Participants will be randomly assigned to one of two groups. The control group will have their calcineurin inhibitor (CNI) drug dose, such as tacrolimus or cyclosporine, reduced and then completely stopped by six months. The investigational group will continue receiving low doses of CNI treatment for two years, with drug levels carefully adjusted from month three through month 24 or until the study ends. Follow-up visits will be scheduled every three months for check-ups and testing. During the study, participants will undergo regular clinical visits every three months over a two-year period to monitor health and treatment effects. Researchers will assess the degree of HLA sensitization as the primary outcome at two years. Additional measures include monitoring mortality, hospitalization days, transplant listing status, infections, cardiovascular events, cancer, graft intolerance, renal function, immune cell counts, and adverse events. These evaluations help track safety and treatment impact throughout the study duration.

Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure