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

NCT00294515

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Cytomegalovirus Infections

Interventions: Valganciclovir, Valganciclovir

Countries: United States, Australia, Belgium, Brazil, Canada, France, Germany, Italy

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.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (80)
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Hackensack, New Jersey, United States
  • Livingston, New Jersey, United States
  • New Brunswick, New Jersey, United States
  • Winston-Salem, North Carolina, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • San Antonio, Texas, United States
  • San Antonio, Texas, United States
  • Seattle, Washington, United States
  • Camperdown, New South Wales, Australia
  • Clayton, Victoria, Australia
  • Parkville, Victoria, Australia
  • Brussels, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Porto Alegre, Rio Grande do Sul, Brazil
  • + 50 more on CT.gov