Study Comparing Preemptive Therapy and Prophylaxis with Valganciclovir or Letermovir to Prevent Cytomegalovirus Disease in Adult Kidney Transplant Recipients from CMV-Positive Donors

What this Trial Is About

Researchers are evaluating two strategies to prevent cytomegalovirus CMV disease in adult kidney transplant recipients who received an organ from a CMV-positive donor but are themselves CMV-negative. This prospective, randomized, multicenter Phase 3 trial compares preemptive therapy PET to antiviral prophylaxis AP to see which is more effective in preventing CMV disease. Approximately 360 participants will be enrolled and followed for up to 5.5 years post-transplant to assess clinical, laboratory, immunologic, and safety outcomes. Participants will be randomly assigned within 7 days of transplant to either receive antiviral prophylaxis with oral valganciclovir once daily or letermovir once daily for 200 days post-transplant, or to preemptive therapy involving weekly blood tests to monitor CMV DNA levels for 100 days post-transplant. Those in the preemptive therapy group will start oral valganciclovir twice daily only if CMV DNA is detected and continue until two consecutive weekly tests show no viral DNA. Doses are adjusted according to kidney function. During the study, participants will undergo regular blood tests to monitor CMV levels, kidney function, and immune response, as well as assessments for any CMV disease or complications. The main outcome measured is the incidence of confirmed CMV disease within one year after transplant. Other outcomes include time to acute rejection, graft loss, death, and kidney function over several years. Participants will be followed until withdrawal, death, or study closure, with ongoing safety monitoring throughout.

Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients