Historical Controlled, Single Center Open Label Pilot Comparing the Effectiveness and Tolerability of De-novo Initiation of Letermovir Versus Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation. There are two arms in the study: Arm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African American Kidney recipients who will be on prophylactic Letermovir for 6 month. Arm 2: Prophylaxis: This group includes high-risk African American kidney transplant recipients who had already completed the 6 month prophylactic course with the standard of care Valganciclovir.
• Kidney transplant recipients
• Male or female age ≥ 18 years old
• African American race
• CMV high risk (D+/R-)
• received valganciclovir for CMV prophylaxis
⁃ Historical Control group:
⁃ Exclusion
• Re-transplantation
• Panel of reactive antibody ≥80% at the time of transplant
• Positive cytotoxic cross match at the time of transplant
⁃ Experimental Group Inclusion Criteria
• Kidney transplant recipients
• Male or female age ≥ 18 years old
• African American race
• CMV high risk (D+/R-)
• Ability to provide informed consent before any trial related activities