drugset / Trial / NCT07571135

Letermovir vs Valganciclovir in CMV R+ Kidney Transplant

NCT07571135

Phase 4 Not yet recruiting 300 enrolled Elisabeth Kincaide
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant. The main question the study wants to answer is: • Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant? The study will also look at other important questions: * Is letermovir easier for patients to tolerate than valganciclovir? * How long does it take for a CMV infection to appear in each group? * Are there differences in "breakthrough" CMV infections between the two medications? * For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups

Timeline

Start
2026-05
Primary completion
2028-11
Completion
2028-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Letermovir Small molecule 240 mg Oral
Comparator Letermovir Small molecule 480 mg Oral
Subject Valganciclovir Small molecule 450 mg Oral