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

NCT03443869 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 601

Last updated 2023-07-28

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2022-04-05
Completion
2022-04-05
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Colombia
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • New Zealand
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443869 on ClinicalTrials.gov