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MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)

A Phase 3, Open-Label, Single-Arm Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of MK-8228 (Letermovir) for the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients

NCT04129398•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety, efficacy and pharmacokinetics (PK) of Letermovir (LET) administered as prevention of cytomegalovirus (CMV) infection and disease in adult Japanese kidney transplant recipients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meets recipient and/or donor CMV Immunoglobulin G (IgG) serostatus.
•Anticipates receiving a primary or secondary allograft kidney at the time of screening and have received a primary or secondary allograft kidney at the time of allocation.
•Is within 0 (i.e., day of transplantation) to 7 days (inclusive) post-kidney transplant at the time of allocation.
•Is a Japanese male or female from 18 years to any years of age inclusive, at the time of signing the informed consent.
•Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP); but if a WOCBP, she is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse, and must have a negative highly sensitive pregnancy test within 72 hours before the first dose of study intervention.

Exclusion Criteria

•Has received a previous solid organ transplant or hematopoietic stem cell transplant (HSCT).
•Is a multi-organ transplant recipient (e.g., kidney-pancreas).
•Has a history of CMV disease or suspected CMV disease within 6 months prior to allocation.
•Has positive results on CMV assay and/or CMV antigen test at any time between the completion of the transplant surgery and time of allocation.
•Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
•Is on dialysis (for the purposes of this protocol dialysis includes hemofiltration) or plasmapheresis at the time of allocation.
•Has Child-Pugh Class C severe hepatic insufficiency at screening.
•Has post-transplant renal function of creatinine clearance (CrCl) ≤10 mL/min at allocation (measured locally).
•Has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency at screening.
•Has any uncontrolled infection on the day of allocation.
+13 more criteria

Locations (4)

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital ( Site 0002)

Nagoya, Aichi-ken, Japan

Sapporo City General Hospital ( Site 0004)

Sapporo, Hokkaido, Japan

Osaka University Hospital ( Site 0003)

Suita, Osaka, Japan

Tokyo Women's Medical University Hospital ( Site 0001)

Tokyo, Japan

Key Dates

Start Date

December 27, 2019

Primary Completion Date

October 6, 2022

Completion Date

October 6, 2022

Last Updated

August 21, 2024

Enrollment

ACTUAL participants

Conditions

Cytomegalovirus InfectionCytomegalovirus Disease

Interventions

Letermovir tablet

DRUG

Letermovir IV

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)

Inclusion Criteria

Exclusion Criteria

Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

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A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults

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