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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Cytomegalovi

Brief Summary: 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.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant [ Time Frame: 12 months post-transplant ]

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.


Original Primary Outcome: Proportion of patients who develop CMV disease within the first 52 weeks post-transplant

Current Secondary Outcome:

  • Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant [ Time Frame: 6 months post-transplant ]
    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 ]
    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 ]
    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 ]
    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.


Original Secondary Outcome: Efficacy: Proportion of patients with CMV disease; time to CMV disease; proportion of patients with, and time to, CMV viremia; seroconversion; proportion with acute rejection, survival safety

Information By: Hoffmann-La Roche

Dates:
Date Received: February 21, 2006
Date Started: March 2006
Date Completion:
Last Updated: July 30, 2010
Last Verified: July 2010