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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00294515
First received: February 21, 2006
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Cytomegalovirus Infections
Drug: Valganciclovir
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant [ Time Frame: 12 months post-transplant ] [ Designated as safety issue: No ]
    Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.


Secondary Outcome Measures:
  • Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant [ Time Frame: 6 months post-transplant ] [ Designated as safety issue: No ]
    Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.

  • Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant [ Time Frame: 9 months post-transplant ] [ Designated as safety issue: No ]
    Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant.

  • Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant [ Time Frame: 18 months post-transplant ] [ Designated as safety issue: No ]
    Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant.

  • Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant [ Time Frame: 24 months post-transplant ] [ Designated as safety issue: No ]
    Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant.


Enrollment: 326
Study Start Date: March 2006
Study Completion Date: August 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valganciclovir up to 100 days
Valganciclovir for up to 100 days post kidney transplant
Drug: Valganciclovir
900 mg orally daily for up to 100 days
Other Name: Valcyte
Active Comparator: Valganciclovir up to 200 days
Valganciclovir for up to 200 days post kidney transplant
Drug: Valganciclovir
900 mg orally daily for up to 200 days
Other Name: Valcyte

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294515

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90095
San Diego, California, United States, 92103-8401
San Francisco, California, United States, 94115
San Francisco, California, United States, 94143-0116
United States, Florida
Tampa, Florida, United States, 33606
United States, Illinois
Chicago, Illinois, United States, 60612-3824
United States, Indiana
Indianapolis, Indiana, United States, 46202-5124
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0331
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Hackensack, New Jersey, United States, 07601
Livingston, New Jersey, United States, 07039
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Winston-salem, North Carolina, United States, 27157-1082
United States, Oregon
Portland, Oregon, United States, 97201
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19102-1192
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
San Antonio, Texas, United States, 78284
San Antonio, Texas, United States, 78229
United States, Washington
Seattle, Washington, United States, 98195
Australia
Camperdown, Australia, 2050
Clayton, Australia, 3186
Parkville, Australia, 3050
Belgium
Bruxelles, Belgium, 1070
Gent, Belgium, 9000
Leuven, Belgium, 3000
Brazil
Campinas, Brazil, 13083-970
Porto Alegre, Brazil, 90240-520
Porto Alegre, Brazil, 90035-003
Sao Paulo, Brazil, 05651-901
Sao Paulo, Brazil, 18048-900
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2S2
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
Toronto, Ontario, Canada, M5G 1L7
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
France
Bordeaux, France, 33076
Grenoble, France, 38043
Montpellier, France, 34090
Paris, France, 75651
Strasbourg, France, 67091
Toulouse, France, 31054
Tours, France, 37044
Vandoeuvre-les-nancy, France, 54511
Germany
Berlin, Germany, 13353
Berlin, Germany, 10117
Düsseldorf, Germany, 40225
Erlangen, Germany, 91054
Frankfurt Am Main, Germany, 60596
Hannover, Germany, 30625
Lübeck, Germany, 23538
Regensburg, Germany, 93053
Italy
Bari, Italy, 70124
Milano, Italy, 20162
Padova, Italy, 35128
Roma, Italy, 00168
New Zealand
Auckland, New Zealand, 1001
Poland
Krakow, Poland, 31-501
Warszawa, Poland, 02-006
Wroclaw, Poland, 50-417
Romania
Bucharest, Romania, 022328
Cluj Napoca, Romania, 400006
Spain
Barakaldo, Spain
Barcelona, Spain, 08907
Barcelona, Spain, 08035
Madrid, Spain, 28028
Madrid, Spain
Valencia, Spain, 46017
United Kingdom
Antrim, United Kingdom, 2RL
Birmingham, United Kingdom, B15 2TH
Bristol, United Kingdom, BS1 05NB
Glasgow, United Kingdom, G11 6NT
Liverpool, United Kingdom, L7 8XP
London, United Kingdom, E1 1BB
Manchester, United Kingdom, M13 9WL
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Nottingham, United Kingdom, NG5 1PB
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00294515     History of Changes
Other Study ID Numbers: NT18435
Study First Received: February 21, 2006
Results First Received: June 2, 2010
Last Updated: July 30, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014