NCT03443869

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.

Conditions

• CMV Disease

Interventions

Type	Name	Description
DRUG	Letermovir	LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks
DRUG	Valganciclovir	900 mg VGCV tablet orally, once daily for 28 weeks
DRUG	Acyclovir (ACV)	400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks
DRUG	Placebo to ACV	Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks
DRUG	Placebo to LET	Placebo to LET tablet orally, once daily for 28 weeks
DRUG	Placebo to VGCV	Placebo to VGCV tablet orally, once daily for 28 weeks

Timeline

• Start date: 2018-05-03
• Primary completion: 2022-04-05
• Completion: 2022-04-05
• First posted: 2018-02-23
• Last updated: 2023-07-28
• Results posted: 2023-04-14

Locations

94 sites across 16 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Colombia, France, Germany, Hungary, Italy, Mexico, New Zealand, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study