Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
NCT ID: NCT03443869
Last Updated: 2023-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
601 participants
INTERVENTIONAL
2018-05-03
2022-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Letermovir
LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to VGCV tablet orally once daily; and 400 mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks
Letermovir
LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks
Acyclovir (ACV)
400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks
Placebo to VGCV
Placebo to VGCV tablet orally, once daily for 28 weeks
Valganciclovir
900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Valganciclovir
900 mg VGCV tablet orally, once daily for 28 weeks
Placebo to ACV
Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks
Placebo to LET
Placebo to LET tablet orally, once daily for 28 weeks
Interventions
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Letermovir
LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks
Valganciclovir
900 mg VGCV tablet orally, once daily for 28 weeks
Acyclovir (ACV)
400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks
Placebo to ACV
Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks
Placebo to LET
Placebo to LET tablet orally, once daily for 28 weeks
Placebo to VGCV
Placebo to VGCV tablet orally, once daily for 28 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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UAB ( Site 0269)
Birmingham, Alabama, United States
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
Virginia Commonwealth University ( Site 0245)
Richmond, Virginia, United States
University of Washington Medical Center ( Site 0246)
Seattle, Washington, United States
Hospital El Cruce Nestor Carlos Kirchner ( Site 0351)
San Juan Bautista, Buenos Aires, Argentina
CEMIC ( Site 0352)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto de Nefrologia Nephrology S.A. ( Site 0182)
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires ( Site 0188)
CABA, , Argentina
Instituto de Cardiología de Corrientes Juana F. Cabral ( Site 0181)
Corrientes, , Argentina
Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0354)
Santa Fe, , Argentina
Royal Prince Alfred Hospital ( Site 0005)
Camperdown, New South Wales, Australia
Westmead Hospital ( Site 0006)
Westmead, New South Wales, Australia
Princess Alexandra Hospital ( Site 0004)
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital ( Site 0003)
Adelaide, South Australia, Australia
Monash Health-Monash Medical Centre ( Site 0008)
Clayton, Victoria, Australia
Royal Melbourne Hospital ( Site 0007)
Parkville, Victoria, Australia
Medizinische Universitat Innsbruck ( Site 0033)
Innsbruck, Tyrol, Austria
Allgemeines Krankenhaus Universitaetskliniken Wien ( Site 0032)
Vienna, , Austria
Universitair Ziekenhuis Antwerpen ( Site 0041)
Edegem, Antwerpen, Belgium
Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 0042)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Leuven - Campus Gasthuisberg ( Site 0044)
Leuven, Vlaams-Brabant, Belgium
University of Alberta Hospital ( Site 0221)
Edmonton, Alberta, Canada
Vancouver General Hospital ( Site 0224)
Vancouver, British Columbia, Canada
St. Paul's Hospital ( Site 0225)
Vancouver, British Columbia, Canada
Toronto General Hospital ( Site 0222)
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0226)
Montreal, Quebec, Canada
Hospital San Vicente Fundación - Rionegro ( Site 0205)
Rionegro, Antioquia, Colombia
Clinica del Country ( Site 0208)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0209)
Bogotá, Bogota D.C., Colombia
Hospital Universitario Mayor Mederi CIMED ( Site 0206)
Bogotá, Bogota D.C., Colombia
Sociedad de Cirugia de Bogota Hospital de San Jose ( Site 0203)
Bogotá, Bogota D.C., Colombia
Fundacion Cardiovascular de Colombia ( Site 0210)
Bucaramanca, Santander Department, Colombia
Fundacion Valle del Lili ( Site 0285)
Cali, Valle del Cauca Department, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0201)
Cali, Valle del Cauca Department, Colombia
Hopital Pasteur ( Site 0053)
Nice, Alpes-Maritimes, France
CHU de Bordeaux. Hopital Pellegrin ( Site 0055)
Bordeaux, Gironde, France
CHU Rangueil ( Site 0054)
Toulouse, Haute-Garonne, France
C.H.R.U Bretonneau ( Site 0051)
Tours, Indre-et-Loire, France
Hopital Henri Mondor du Creteil ( Site 0063)
Créteil, Val-de-Marne, France
CHU - Hopital de Bicetre ( Site 0060)
Le Kremlin-Bicêtre, Val-de-Marne, France
Hopital Tenon ( Site 0061)
Paris, , France
Medizinische Hochschule Hannover ( Site 0073)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Essen ( Site 0074)
Essen, North Rhine-Westphalia, Germany
Charite Universitaetsmedizin Berlin ( Site 0071)
Berlin, , Germany
Pecsi Tudomanyegyetem AOK ( Site 0282)
Pécs, Baranya, Hungary
Szegedi Tudomanyegyetem ( Site 0284)
Szeged, Csongrád megye, Hungary
Semmelweis Egyetem ( Site 0281)
Budapest, , Hungary
Debreceni Egyetem. ( Site 0283)
Debrecen, , Hungary
A.O.U. Citta della Salute e della Scienza di Torino ( Site 0096)
Turin, Piedmont, Italy
Azienda Ospedaliera di Padova U.O.C. Trapianti Rene e Pancreas ( Site 0091)
Padua, Veneto, Italy
IRCCS Ospedale San Raffaele di Milano ( Site 0098)
Milan, , Italy
Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 0093)
Roma, , Italy
Instituto Mexicano de Trasplantes S C ( Site 0212)
Cuernavaca, Morelos, Mexico
Centenario Hospital Miguel Hidalgo ( Site 0215)
Aguascalientes, , Mexico
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0213)
Mexico City, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0214)
Mexico City, , Mexico
Faicic S de RL de CV ( Site 0211)
Veracruz, , Mexico
Auckland City Hospital ( Site 0002)
Auckland, , New Zealand
Szpital Wojewodzki w Poznaniu ( Site 0168)
Poznan, Greater Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0162)
Wroclaw, Lower Silesian Voivodeship, Poland
Szpital Kliniczny Dzieciatka Jezus ( Site 0165)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne ( Site 0170)
Gdansk, Pomeranian Voivodeship, Poland
Pomorski Uniwersytet Medyczny ( Site 0167)
Szczecin, West Pomeranian Voivodeship, Poland
Hospital del Mar ( Site 0121)
Barcelona, La Coruna, Spain
Hospital Universitari de Bellvitge IDIBELL ( Site 0114)
L'Hospitalet de Llobregat, La Coruna, Spain
Hospital Universitari Vall de Hebron ( Site 0112)
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona ( Site 0113)
Barcelona, , Spain
Hospital Doce de Octubre ( Site 0116)
Madrid, , Spain
Hospital Universitario Miguel Servet ( Site 0118)
Zaragoza, , Spain
St Georges University Hospitals NHS Foundation Trust. ( Site 0136)
London, London, City of, United Kingdom
Queen Elizabeth Hospital ( Site 0356)
Birmingham, , United Kingdom
Countries
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References
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Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.
Strizki JM, Diamond TL, Teal VL, Gilbert CL, Wang W, Stauffer N, Haber BA. Cytomegalovirus Antiviral Resistance Among Kidney Transplant Recipients in a Phase 3 Trial of Letermovir vs Valganciclovir Prophylaxis. J Infect Dis. 2024 Dec 16;230(6):e1287-e1298. doi: 10.1093/infdis/jiae287.
Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Merck Clinical Trial Information
Other Identifiers
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MK-8228-002
Identifier Type: OTHER
Identifier Source: secondary_id
2017-001055-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8228-002
Identifier Type: -
Identifier Source: org_study_id
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