NCT00294515

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	Valganciclovir	900 mg orally daily for up to 100 days
DRUG	Valganciclovir	900 mg orally daily for up to 200 days

Timeline

• Start date: 2006-03-31
• Primary completion: 2008-08-31
• Completion: 2009-08-31
• First posted: 2006-02-22
• Last updated: 2018-03-29
• Results posted: 2010-07-05

Locations

80 sites across 13 countries: United States, Australia, Belgium, Brazil, Canada, France, Germany, Italy, New Zealand, Poland, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study