Phase II Study Comparing Donor Modified Immune Cells MIC Therapy to Standard Immunosuppression in Adults Undergoing Living Donor Kidney Transplantation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an investigational medicine called MIC in patients undergoing living donor kidney transplantation. This Phase II clinical trial involves 63 pairs of donors and recipients randomly assigned to one of three groups. The purpose is to compare MIC therapy combined with different immunosuppressive regimens against standard care to see if MIC can improve transplant outcomes and reduce rejection risks. Patients in the MIC groups receive MIC as a single intravenous dose based on body weight, prepared from donor blood cells collected through leukapheresis. Two MIC treatment arms use different levels of immunosuppression with gradual reduction of medications like tacrolimus and corticosteroids. The control group receives standard immunosuppressive treatment without MIC. Following transplantation, all patients are monitored for one year, followed by an additional two years of safety observation. Participants will have regular visits during the 12-month follow-up to assess kidney function, immune responses, infection rates, and quality of life through lab tests, biopsies, and questionnaires. Researchers will track outcomes such as rejection episodes, antibody development, survival rates, and medication use. Long-term monitoring will continue for two years post-trial to evaluate ongoing safety and transplant health.

Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation