At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 326 enrolled
Drug / intervention
Valganciclovir +1 moredrug
Likely dose
Valganciclovir 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Valganciclovir for Cytomegalovirus Infections. Completed, enrolled 326 participants across 80 sites in 13 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Infections
CountriesAustralia, Belgium, Brazil, Canada, France, Germany, Italy, New Zealand, Poland, Romania, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2006
Enrollment StartMar 2006
Primary CompletionAug 2008
Study CompletionAug 2009
TodayJul 2026
First PostedFeb 22, 2006
Enrollment StartMar 31, 2006
Primary CompletionAug 31, 2008
Study CompletionAug 31, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.4 years ago
Interventions
Valganciclovirdrug
900 mg orally daily for up to 100 days
Valganciclovirdrug
900 mg orally daily for up to 200 days