A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients

PHASE2CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

December 14, 2012

Primary Completion Date

October 15, 2014

Study Completion Date

October 15, 2014

Conditions
Cytomegalovirus Infections
Interventions
DRUG

MCMV3068A

Four doses of MCMV3068A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.

DRUG

MCMV5322A

Four doses of MCMV5322A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.

DRUG

Placebo

Four doses of placebo matched to MCMV5322A/MCMV3068A administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.

Trial Locations (39)

1070

Clin Univ de Bxl Hôpital Erasme, Brussels

3000

UZ Leuven Gasthuisberg, Leuven

9000

UZ Gent, Ghent

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University, New York

14215

Erie County Medical Center; Dept. of Nephrology, Buffalo

20007

Georgetown Uni Hospital; Division of Transplant Surgery, Washington D.C.

20010

MedStar Washington Hosp Center, Washington D.C.

30322

Emory University, Atlanta

30912

Georgia Regents University, Augusta

31059

Hopital Rangueil; Gastro Enterologie Et Nutrition, Toulouse

33076

Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie, Bordeaux

37000

Chu De Tours, Tours

41013

CEIC del Hospital Virgen del Rocío, Seville

44093

CHU de Nantes; Institut de transplantation urologie-néphrologie, Nantes

45122

Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie, Essen

45267

University of Cincinnati / University of Cincinnati College of Medicine, Cincinnati

54511

Hopitaux De Brabois; Nephrologie, Vandœuvre-lès-Nancy

60596

Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III, Frankfurt

63110

Washington Uni School of Medicine/Barnes Jewish Hospital; Renal, St Louis

69120

Uniklinikum Heidelberg, Heidelberg

75246

Baylor Univ Medical Center, Dallas

75743

Hopital Necker, Paris

80262

University of Colorado Health Sciences Center; Dept of Medicine, Denver

90095

UCLA; Kidney & Pancreas Transplantation, Los Angeles

92123

California Inst. of Renal Research, San Diego

94143-0780

Univ of CA San Francisco; Kidney Transplant Service, San Francisco

48202-2689

Henry Ford Health System; Gastroenterology, Detroit

01307

"Universitätsklinikum Carl Gustav Carus; Medizinische Klinik III", Dresden

0372

Oslo Universitetssykehus HF, Rikshospitalet, Oslo

08025

Fundació Puigvert, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

413 45

Sahlgrenska Universitetssjukhuset; Jubileumskliniken, Gothenburg

141 86

Karolinska University Hospital, Huddinge

751 85

Akademiska Sjukhuset; Transplantation Surgery, Uppsala

NW3 2QS

Royal Free Hospital, London

SE1 9RT

Guys and St Thomas NHS Foundation Trust, Guys Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY