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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:May 3, 2018
End Date:September 19, 2021
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

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.


Inclusion Criteria:

- 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 at the time of randomization.

- 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.
We found this trial at
28
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-613-6472
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-525-8014
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-1665
University of Chicago One of the world's premier academic and research institutions, the University of...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 317-948-0633
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-343-8010
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-648-6553
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Sacramento, California 95814
Phone: 916-734-8033
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Atlanta, Georgia 30322
Phone: 404-727-8435
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: 443-287-4694
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Phone: 410-328-0303
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Birmingham, Alabama 35249
Phone: 205-934-5191
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Buenos Aires,
Phone: +541148022720
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-8358
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-293-4997
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Phone: 313-916-3709
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Phone: 973-322-8467
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Los Angeles, California 90095
Phone: 310-794-8516
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New Orleans, Louisiana 70121
Phone: 504-842-5527
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630 W 168th St
New York, New York
212-305-2862
Phone: 212-305-3839
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10021
Phone: 212-746-6320
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Phone: 212-241-0255
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-559-8609
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-662-4007
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Richmond, Virginia 23298
(804) 828-0100
Phone: 804-828-4090
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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San Francisco, California 94143
Phone: 415-353-8389
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Phone: 206-598-1041
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Stanford, California 94304
Phone: 650-723-7362
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Phone: 336-716-9353
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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