Trial Information

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

Status: No longer recruiting

Protocol Number: NT18435

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study to compare the effect of up to 100 days, and up to 200 days, of treatment with Valcyte (valganciclovir) on prevention of cytomegalovirus disease in high-risk kidney allograft recipients

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. Target sample size is 316.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Placebo
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Cytomegalovirus infections

Intervention Type: Drug

Intervention Name: valganciclovir [Valcyte]

Primary Outcome: Percentage of patients who develop CMV disease. Timeframe: First 52 weeks post-transplant

Key Secondary Outcomes: Percentage of patients who develop CMV disease; time to CMV disease; CMV viremia; seroconversion; acute rejection; survival. Timeframe: Event driven. AEs, laboratory parameters. Timeframe: Throughout study.

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.

Gender: Males or Females

Age Limits: Min: 16 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: March, 2006

Trial Registration Date: 03/10/2006

Date Last Updated: 02/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Berlin, Germany, 14165
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: October 6, 2008 at 2:47:21 PM


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