Comparing Rabbit Anti-Thymocyte Globulin and Basiliximab for Induction Therapy in Sensitized Kidney Transplant Recipients Without Donor-Specific Antibodies

What this Trial Is About

This trial evaluates induction therapies in kidney transplant recipients KTRs who are sensitized but do not have pre-existing donor-specific antibodies DSAs. It compares the use of rabbit anti-thymocyte globulin rATG and basiliximab to understand their efficacy and safety in preventing acute rejection. The study addresses uncertainties about the immunological risk and treatment benefits in this specific patient group, where the balance between reducing rejection and avoiding side effects is not well known. Participants receive either rATG or basiliximab as induction therapy around the time of transplantation. The rATG is infused over 3 to 7 days starting just before surgery, alongside tacrolimus dosing, while basiliximab is given as two intravenous infusions before and shortly after surgery. Both treatments are widely used in practice, but this trial aims to directly compare their outcomes in sensitized KTRs without DSAs. During the study, participants will be followed for up to three years to monitor kidney transplant rejection confirmed by biopsy, development of new DSAs, infections like CMV and BK virus, kidney function, and safety events. Researchers will assess outcomes at one and three years post-transplant, including economic evaluations. Participants undergo regular clinical assessments, laboratory tests, and biopsies as needed to track these measures and ensure thorough monitoring throughout the trial period.

Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies