drugset / Trial / NCT06001320

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

NCT06001320

Phase 3 Active not recruiting 30 enrolled Virginia Commonwealth University Merck Sharp & Dohme LLC · collab
Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2023-09-25
Primary completion
2026-09-01
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Letermovir Small molecule 480 mg Oral