drugset / Trial / NCT06001320
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letermovir | Small molecule | 480 mg | Oral |