IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

Condition(s) targeted: Cytomegalovirus Infections

Intervention: Valganciclovir (Drug); Valganciclovir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Chair, Affiliation: Hoffmann-La Roche

This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant

Secondary outcome:

Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant

Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant

Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant

Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ≥ 16 years of age

- CMV seronegative recipient of primary or secondary renal allograft from a living or

cadaveric seropositive donor

- Adequate hematological and renal function

- Patients and partners must agree to maintain effective birth control for 90 days

following cessation of study medication Exclusion Criteria:

- CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening

- Multi-organ transplant recipient

- Hepatitis B, hepatitis C or HIV positive

- Women who are pregnant or lactating

Camperdown 2050, Australia

Clayton 3186, Australia

Parkville 3050, Australia

Bruxelles 1070, Belgium

Gent 9000, Belgium

Leuven 3000, Belgium

Campinas 13083-970, Brazil

Porto Alegre 90035-003, Brazil

Porto Alegre 90240-520, Brazil

Sao Paulo 05651-901, Brazil

Sao Paulo 18048-900, Brazil

Bordeaux 33076, France

Grenoble 38043, France

Montpellier 34090, France

Paris 75651, France

Strasbourg 67091, France

Toulouse 31054, France

Tours 37044, France

Vandoeuvre-les-nancy 54511, France

Berlin 10117, Germany

Berlin 13353, Germany

Düsseldorf 40225, Germany

Erlangen 91054, Germany

Frankfurt Am Main 60596, Germany

Hannover 30625, Germany

Lübeck 23538, Germany

Regensburg 93053, Germany

Bari 70124, Italy

Milano 20162, Italy

Padova 35128, Italy

Roma 00168, Italy

Auckland 1001, New Zealand

Krakow 31-501, Poland

Warszawa 02-006, Poland

Wroclaw 50-417, Poland

Bucharest 022328, Romania

Cluj Napoca 400006, Romania

Barakaldo, Spain

Barcelona 08035, Spain

Barcelona 08907, Spain

Madrid 28028, Spain

Madrid, Spain

Valencia 46017, Spain

Antrim 2RL, United Kingdom

Birmingham B15 2TH, United Kingdom

Bristol BS1 05NB, United Kingdom

Glasgow G11 6NT, United Kingdom

Liverpool L7 8XP, United Kingdom

London E1 1BB, United Kingdom

Manchester M13 9WL, United Kingdom

Newcastle Upon Tyne NE7 7DN, United Kingdom

Nottingham NG5 1PB, United Kingdom

Oxford OX3 7LJ, United Kingdom

Birmingham, Alabama 35294, United States

Edmonton, Alberta T6G 2S2, Canada

Los Angeles, California 90057, United States

Los Angeles, California 90095, United States

San Diego, California 92103-8401, United States

San Francisco, California 94115, United States

San Francisco, California 94143-0116, United States

Tampa, Florida 33606, United States

Chicago, Illinois 60612-3824, United States

Indianapolis, Indiana 46202-5124, United States

Boston, Massachusetts 02111, United States

Ann Arbor, Michigan 48109-0331, United States

Minneapolis, Minnesota 55455, United States

Hackensack, New Jersey 07601, United States

Livingston, New Jersey 07039, United States

New Brunswick, New Jersey 08901, United States

Winston-salem, North Carolina 27157-1082, United States

Hamilton, Ontario L8N 4A6, Canada

Toronto, Ontario M5G 1L7, Canada

Portland, Oregon 97201, United States

Philadelphia, Pennsylvania 19102-1192, United States

Philadelphia, Pennsylvania 19104, United States

Montreal, Quebec H3A 1A1, Canada

Nashville, Tennessee 37232, United States

San Antonio, Texas 78229, United States

San Antonio, Texas 78284, United States

Seattle, Washington 98195, United States

Clinical Study Report Synopsis

Starting date: March 2006
Last updated: July 30, 2010