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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
History of Changes
  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:

U.S. FDA Resources

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

  Show 80 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Clinical Study Report Synopsis  This link exits the ClinicalTrials.gov site

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 May 19, 2013