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

PHASE3CompletedINTERVENTIONAL
Enrollment

601

Participants

Timeline

Start Date

May 3, 2018

Primary Completion Date

April 5, 2022

Study Completion Date

April 5, 2022

Conditions
CMV Disease
Interventions
DRUG

Letermovir

LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks

DRUG

Valganciclovir

900 mg VGCV tablet orally, once daily for 28 weeks

DRUG

Acyclovir (ACV)

400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks

DRUG

Placebo to ACV

Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks

DRUG

Placebo to LET

Placebo to LET tablet orally, once daily for 28 weeks

DRUG

Placebo to VGCV

Placebo to VGCV tablet orally, once daily for 28 weeks

Trial Locations (94)

1070

Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 0042), Brussels

1082

Semmelweis Egyetem ( Site 0281), Budapest

1090

Allgemeines Krankenhaus Universitaetskliniken Wien ( Site 0032), Vienna

1142

Auckland City Hospital ( Site 0002), Auckland

2050

Royal Prince Alfred Hospital ( Site 0005), Camperdown

2145

Westmead Hospital ( Site 0006), Westmead

2650

Universitair Ziekenhuis Antwerpen ( Site 0041), Edegem

3000

UZ Leuven - Campus Gasthuisberg ( Site 0044), Leuven

3050

Royal Melbourne Hospital ( Site 0007), Parkville

3168

Monash Health-Monash Medical Centre ( Site 0008), Clayton

4032

Debreceni Egyetem. ( Site 0283), Debrecen

4102

Princess Alexandra Hospital ( Site 0004), Woolloongabba

5000

Royal Adelaide Hospital ( Site 0003), Adelaide

6020

Medizinische Universitat Innsbruck ( Site 0033), Innsbruck

6725

Szegedi Tudomanyegyetem ( Site 0284), Szeged

7624

Pecsi Tudomanyegyetem AOK ( Site 0282), Pécs

10029

Icahn School of Medicine at Mount Sinai ( Site 0256), New York

10032

Columbia University Medical Center ( Site 0255), New York

10065

New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 0276), New York

10117

Charite Universitaetsmedizin Berlin ( Site 0071), Berlin

10126

A.O.U. Citta della Salute e della Scienza di Torino ( Site 0096), Turin

14080

Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0213), Mexico City

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0214), Mexico City

15213

University of Pittsburgh ( Site 0252), Pittsburgh

19104

University of Pennsylvania ( Site 0270), Philadelphia

20132

IRCCS Ospedale San Raffaele di Milano ( Site 0098), Milan

20259

Centenario Hospital Miguel Hidalgo ( Site 0215), Aguascalientes

21201

University of Maryland Medical Center ( Site 0234), Baltimore

21287

Johns Hopkins Hospital ( Site 0232), Baltimore

23298

Virginia Commonwealth University ( Site 0245), Richmond

27157

Wake Forest University Baptist Medical Center ( Site 0260), Winston-Salem

27710

Duke University Medical Center ( Site 0243), Durham

28041

Hospital Doce de Octubre ( Site 0116), Madrid

29425

Medical University of South Carolina ( Site 0257), Charleston

30322

The Emory Clinic ( Site 0247), Atlanta

30625

Medizinische Hochschule Hannover ( Site 0073), Hanover

31059

CHU Rangueil ( Site 0054), Toulouse

33076

CHU de Bordeaux. Hopital Pellegrin ( Site 0055), Bordeaux

35128

Azienda Ospedaliera di Padova U.O.C. Trapianti Rene e Pancreas ( Site 0091), Padua

35233

UAB ( Site 0269), Birmingham

37232

Vanderbilt University Medical Center ( Site 0275), Nashville

43210

The Ohio State University Wexner Medical Center ( Site 0264), Columbus

44093

C.H.R.U Bretonneau ( Site 0051), Tours

45147

Universitaetsklinikum Essen ( Site 0074), Essen

46202

Indiana University ( Site 0261), Indianapolis

48202

Henry Ford Hospital ( Site 0242), Detroit

50009

Hospital Universitario Miguel Servet ( Site 0118), Zaragoza

51069

Hopital Pasteur ( Site 0053), Nice

60637

University of Chicago ( Site 0251), Chicago

62448

Instituto Mexicano de Trasplantes S C ( Site 0212), Cuernavaca

68198

University of Nebraska Medical Center ( Site 0272), Omaha

70121

Ochsner Clinic Foundation ( Site 0238), New Orleans

75020

Hopital Tenon ( Site 0061), Paris

90095

UCLA Medical Center ( Site 0266), Los Angeles

91900

Faicic S de RL de CV ( Site 0211), Veracruz

94000

Hopital Henri Mondor du Creteil ( Site 0063), Créteil

94143

University of California-San Francisco ( Site 0236), San Francisco

94270

CHU - Hopital de Bicetre ( Site 0060), Le Kremlin-Bicêtre

94305

Stanford Health Care ( Site 0235), Stanford

95817

UC Davis Medical Center ( Site 0271), Sacramento

98195

University of Washington Medical Center ( Site 0246), Seattle

110221

Clinica del Country ( Site 0208), Bogotá

110311

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0209), Bogotá

110911

Hospital Universitario Mayor Mederi CIMED ( Site 0206), Bogotá

111411

Sociedad de Cirugia de Bogota Hospital de San Jose ( Site 0203), Bogotá

680003

Fundacion Cardiovascular de Colombia ( Site 0210), Bucaramanca

760032

Fundacion Valle del Lili ( Site 0285), Santiago de Cali

760042

Centro Medico Imbanaco de Cali S.A ( Site 0201), Santiago de Cali

02115

Brigham & Women's Hospital ( Site 0244), Boston

07039

Saint Barnabas Medical Center ( Site 0250), Livingston

B1073ABA

Hospital El Cruce Nestor Carlos Kirchner ( Site 0351), San Juan Bautista

C1431FWO

CEMIC ( Site 0352), Buenos Aires

C1425APQ

Instituto de Nefrologia Nephrology S.A. ( Site 0182), Buenos Aires

C1199ABD

Hospital Italiano de Buenos Aires ( Site 0188), CABA

W3400AMZ

Instituto de Cardiología de Corrientes Juana F. Cabral ( Site 0181), Corrientes

S3000BPJ

Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0354), Santa Fe

T6G 2B7

University of Alberta Hospital ( Site 0221), Edmonton

V5Z 1M9

Vancouver General Hospital ( Site 0224), Vancouver

V6Z 1Y6

St. Paul's Hospital ( Site 0225), Vancouver

M5G 2N2

Toronto General Hospital ( Site 0222), Toronto

H1T 2M4

Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0226), Montreal

054047

Hospital San Vicente Fundación - Rionegro ( Site 0205), Rionegro

00168

Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 0093), Roma

60-479

Szpital Wojewodzki w Poznaniu ( Site 0168), Poznan

50-556

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0162), Wroclaw

02-006

Szpital Kliniczny Dzieciatka Jezus ( Site 0165), Warsaw

80-952

Uniwersyteckie Centrum Kliniczne ( Site 0170), Gdansk

70-111

Pomorski Uniwersytet Medyczny ( Site 0167), Szczecin

08003

Hospital del Mar ( Site 0121), Barcelona

08907

Hospital Universitari de Bellvitge IDIBELL ( Site 0114), L'Hospitalet de Llobregat

08035

Hospital Universitari Vall de Hebron ( Site 0112), Barcelona

08036

Hospital Clinic i Provincial de Barcelona ( Site 0113), Barcelona

SW17 0QT

St Georges University Hospitals NHS Foundation Trust. ( Site 0136), London

B15 2GW

Queen Elizabeth Hospital ( Site 0356), Birmingham

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03443869 - Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002) | Biotech Hunter | Biotech Hunter