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

  • STATUS
    Recruiting
  • End date
    Aug 18, 2022
  • participants needed
    600
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 1 March 2021

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.

Details
Condition CMV Disease
Treatment Valganciclovir, Letermovir, Acyclovir (ACV), Placebo to ACV, Placebo to LET, Placebo to VGCV
Clinical Study IdentifierNCT03443869
SponsorMerck Sharp & Dohme Corp.
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have CMV Disease?
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
Do you have any of these conditions: Do you have CMV Disease??
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

Exclusion Criteria

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
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