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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-27

Study Completion Date

2022-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03443869

CMV Disease

COMPLETED PHASE3

Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001)

NCT02137772

Prevention of CMV Infection or Disease

COMPLETED PHASE3

Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

NCT05626530

Cytomegalovirus Infections Infection in Solid Organ Transplant Recipients Neutropenia +1 more

RECRUITING PHASE4

Letermovir for the Prevention of CMV Infection in HSCT Recipients Based on the Outcome of mNGS

NCT06021210

CMV Infection Hematopoietic Stem Cell Transplantation

UNKNOWN PHASE2

Letermovir Prophylaxis for CMV Infection in Haplo-HSCT Recipients: Single-center Data in China

NCT05789615

CMV Infection Hematopoietic Stem Cell Transplantation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cytomegalovirus Infection Cytomegalovirus Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Letermovir

Letermovir oral or intravenous (IV) formulation will be administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose will be 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion will be administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.

Group Type EXPERIMENTAL

Letermovir tablet

Intervention Type DRUG

A single 240 mg tablet or two 240 mg tablets letermovir administered orally, once daily for 28 weeks

Letermovir IV

Intervention Type DRUG

IV solution of 240 mg (one vial) or 480 mg (2 vials) letermovir in 250 mL infused over 60 minutes, once daily for 28 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Letermovir tablet

A single 240 mg tablet or two 240 mg tablets letermovir administered orally, once daily for 28 weeks

Intervention Type DRUG

Letermovir IV

IV solution of 240 mg (one vial) or 480 mg (2 vials) letermovir in 250 mL infused over 60 minutes, once daily for 28 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK-8228 PREVYMIS® MK-8228 PREVYMIS®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
* Has documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to allocation, or for hepatitis C virus antibody (HCV-Ab) and with detectable HCV RNA within 90 days prior to allocation or hepatitis B surface antigen (HBsAg) within 90 days prior to allocation.
* Requires mechanical ventilation, or is hemodynamically unstable, at the time of allocation.
* Has a history of malignancy ≤5 years prior to signing informed consent.
* Has received within 30 days prior to allocation or plans to receive during the study any of the following: CMV immune globulin; any investigational CMV antiviral agent/biologic therapy.
* Has received any dose of LET prior to allocation.
* Has received within 7 days prior to allocation or plans to receive during the study any anti-CMV drug therapy.
* Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
* Is taking or plans to take any of the prohibited medications listed in the protocol.
* Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5× half-life of the investigational compound.
* Has previously participated in this study or any other study involving LET.
* Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
* Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 28 days following cessation of study therapy.
* Is expecting to donate eggs starting from the time of consent through at least 28 days following cessation of study therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No