Comparing Two Doses of Siplizumab Versus Rabbit Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection in Adults with Standard Immunosuppressive Treatment

What this Trial Is About

This research aims to evaluate siplizumab, an anti-CD2 monoclonal antibody, for preventing rejection in adults undergoing kidney transplants due to end stage kidney disease. The study compares two different doses of siplizumab with rabbit anti-thymocyte globulin rATG, focusing on safety and how well participants maintain their kidney transplant without rejection or graft loss. The trial also investigates how siplizumab behaves in the body compared to rATG. About 120 adults who need kidney transplants will be randomly assigned to one of three groups two groups receive different doses of siplizumab, and the third receives rATG. All participants will also take standard anti-rejection medicines before, during, and after transplant, along with medicines to reduce reactions and prevent infections. The study includes premedication and background immunosuppressive therapy throughout. Assessments and procedures will continue for 12 months after the transplant. Participants will provide medical and medication histories, undergo physical exams, vital sign checks, blood tests, and heart electrical activity recordings ECGs at various visits. Safety evaluations include viral monitoring, lab tests, and adverse event tracking. The studys main outcome is to assess safety over 12 months, with additional monitoring of transplant success, rejection episodes, and how siplizumab is processed in the body. Follow-up will continue until one year after transplant or study end.

A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant