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

Completed · Phase 3 · Has a placebo group

Conditions studied: CMV Disease

In brief

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.

Key facts

Study ID

NCT03443869

Run by

Merck Sharp & Dohme LLC

People needed

601

Starts

2018-05-03

Expected to finish

2022-04-05

Last updated by the study team

2023-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a documented negative serostatus for CMV within 180 days prior to randomization.
• Anticipate receiving a primary or secondary allograft kidney from a CMV IgG seropositive (D+) donor at the time of screening AND have received a primary or secondary allograft kidney from a documented D+ donor at the time of randomization.
• Be within 0 (i.e. day of transplantation) to 7 days (inclusive) post-kidney transplant at the time of randomization.
• Males agree to use contraception during the treatment period, and for at least 90 days after the last dose of study treatment, and refrain from donating sperm during this period.
• Female is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP), OR if a WOCBP, agrees to follow the contraception guidance during the treatment period and for at least 90 days after the last dose of study treatment.

You may not qualify if…

• Has received a previous solid organ transplant or hematopoietic stem cell transplant (HSCT). Note: Participants who have received a prior primary allograft kidney may be enrolled, provided that all other inclusion/exclusion criteria are met.
• Is a multi-organ transplant recipient (e.g. kidney-pancreas). Double kidney transplant recipients (i.e. transplant of two kidneys from the same donor to the same recipient simultaneously) will be excluded.
• Has a history of CMV disease or suspected CMV disease within 6 months prior to randomization.
• Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations, VGCV, GCV, and/or ACV formulations.
• Is on dialysis or plasmapheresis at the time of randomization. Dialysis includes hemofiltration.
• Has Child-Pugh Class C severe hepatic insufficiency at screening.
• Has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency at screening.
• Has any uncontrolled infection on the day of randomization.
• Has documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus antibody (HCV-Ab) and with detectable HCV ribonucleic acid (RNA) within 90 days prior to randomization, or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization.
• Requires mechanical ventilation, or is hemodynamically unstable, at the time of randomization.
• Has a history of malignancy ≤5 years prior to signing informed consent.
• Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.
• Is expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.
• Has received within 30 days prior to randomization or plans to receive during the study any of the following anti-CMV IgG antibody treatment or anti-CMV drug therapy including the following: Cidofovir, CMV hyper-immune globulin, Any investigational CMV antiviral agent/biologic therapy.
• Has received within 7 days prior to randomization or plans to receive during the study any of the following anti-CMV drug therapy: LET, GCV, VGCV, Foscarnet, ACV, Valacyclovir, Famciclovir.
• 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 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 whichever is longer, of initial dosing on this study.
• 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.

Where it is running

• UCLA Medical Center ( Site 0266) — Los Angeles, California, United States
• UC Davis Medical Center ( Site 0271) — Sacramento, California, United States
• University of California-San Francisco ( Site 0236) — San Francisco, California, United States
• Stanford Health Care ( Site 0235) — Stanford, California, United States
• The Emory Clinic ( Site 0247) — Atlanta, Georgia, United States
• University of Chicago ( Site 0251) — Chicago, Illinois, United States
• Indiana University ( Site 0261) — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation ( Site 0238) — New Orleans, Louisiana, United States
• University of Maryland Medical Center ( Site 0234) — Baltimore, Maryland, United States
• Johns Hopkins Hospital ( Site 0232) — Baltimore, Maryland, United States
• Brigham & Women's Hospital ( Site 0244) — Boston, Massachusetts, United States
• Henry Ford Hospital ( Site 0242) — Detroit, Michigan, United States
• University of Nebraska Medical Center ( Site 0272) — Omaha, Nebraska, United States
• Saint Barnabas Medical Center ( Site 0250) — Livingston, New Jersey, United States
• Icahn School of Medicine at Mount Sinai ( Site 0256) — New York, New York, United States
• Columbia University Medical Center ( Site 0255) — New York, New York, United States
• New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 0276) — New York, New York, United States
• Duke University Medical Center ( Site 0243) — Durham, North Carolina, United States
• Wake Forest University Baptist Medical Center ( Site 0260) — Winston-Salem, North Carolina, United States
• The Ohio State University Wexner Medical Center ( Site 0264) — Columbus, Ohio, United States
• University of Pennsylvania ( Site 0270) — Philadelphia, Pennsylvania, United States
• University of Pittsburgh ( Site 0252) — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina ( Site 0257) — Charleston, South Carolina, United States
• Vanderbilt University Medical Center ( Site 0275) — Nashville, Tennessee, United States
• UAB ( Site 0269) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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