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

February 21, 2006
July 30, 2010
March 2006
August 2008   (final data collection date for primary outcome measure)
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.
Proportion of patients who develop CMV disease within the first 52 weeks post-transplant
Complete list of historical versions of study NCT00294515 on ClinicalTrials.gov Archive Site
  • 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.
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
Not Provided
Not Provided
 
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cytomegalovirus Infections
  • Drug: Valganciclovir
    900 mg orally daily for up to 100 days
    Other Name: Valcyte
  • Drug: Valganciclovir
    900 mg orally daily for up to 200 days
    Other Name: Valcyte
  • Experimental: Valganciclovir up to 100 days
    Valganciclovir for up to 100 days post kidney transplant
    Intervention: Drug: Valganciclovir
  • Active Comparator: Valganciclovir up to 200 days
    Valganciclovir for up to 200 days post kidney transplant
    Intervention: Drug: Valganciclovir
Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
August 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   United States,   Australia,   Belgium,   Brazil,   Canada,   United Kingdom,   Germany,   Italy,   New Zealand,   Poland,   Romania,   Spain
 
NCT00294515
NT18435
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP