Trial information
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 type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
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 Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2006
Trial registration date: 03/10/2006
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Melbourne
- Parkville
- Sydney
Belgium
Brazil
- Campinas
- Porto Alegre
- Sao Paulo
Canada
- Edmonton, AB
- Hamilton, ON
- Toronto, ON
- Montreal, QC
France
- Bordeaux
- Grenoble
- Montpellier
- Nantes
- Paris
- Strasbourg
- Toulouse
- Tours
- Vandoeuvre-Les-Nancy
Germany
- Berlin
- Düsseldorf
- Erlangen
- Hannover
- Lübeck
- Nürnberg
- Regensburg
Italy
New Zealand
Poland
Romania
Spain
- Barcelona
- Bilbao
- Madrid
- Valencia
United Kingdom
- Antrim
- Birmingham
- Bristol
- Glasgow
- Liverpool
- London
- Manchester
- Newcastle upon Tyne
- Nottingham
- Oxford
United States
- Birmingham, AL
- Los Angeles, CA
- San Diego , CA
- San Francisco, CA
- Tampa, FL
- Chicago, IL
- Indianapolis , IN
- Boston, MA
- Ann Arbor, MI
- Minneapolis, MN
- Hackensack, NJ
- Livingston, NJ
- New Brunswick, NJ
- Winston-Salem, NC
- Portland, OR
- Philadelphia, PA
- Nashville, TN
- San Antonio, TX
- Seattle, WA
