Clinical Trial

De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients

Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 2 changes
notable Enrollment reduced: 60 -> 30 participants 2026-04-02
notable Primary completion pushed: 2026-03-01 -> 2026-09-01 2026-04-02
Trial Details
NCT Number NCT06001320
Lead Sponsor Virginia Commonwealth University
Collaborators: Merck Sharp & Dohme LLC
Conditions Kidney Transplant; Complications, CMV
Enrollment 30 participants
Start Date 2023-09-25
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-01