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

This is an interventional prevention trial for Cytomegalovirus Infection Read More

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.