Study of Cytogam CMVIG to Prevent CMV Infection in Kidney Transplant Patients Switching to Belatacept Immunosuppression

What this Trial Is About

This research aims to understand how Cytogam CMVIG interacts with the body and to evaluate if it can help prevent cytomegalovirus CMV infection in adults who have received kidney transplants and are transitioning immunosuppression treatments. The study focuses on kidney transplant recipients who are either switching from traditional immunosuppression to belatacept or are already stable on belatacept. It is a Phase 1 and Phase 2 randomized trial sponsored by the University of Minnesota. Participants will receive Cytogam in one of three dosing schedules a single dose of 150 mgkg on Day 0, two doses of 150 mgkg on Day 0 and Day 7, or two doses on Day 0 and Day 28. Belatacept will be given as standard care via intravenous infusion over 30 minutes in an outpatient infusion center. Cytogam infusion starts about 30 minutes after the belatacept infusion is completed. Throughout the study, researchers will monitor anti-CMV IgG antibody levels before infusion on Day 0 and on Days 7, 14, 21, 28, and 56 after the last dose of Cytogam. Participants will be followed closely to assess how the antibody levels change over time. The study involves regular outpatient visits for infusions and blood tests, with the total observation period lasting at least 56 days after the final Cytogam dose.

CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients