At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 57 enrolled
Drug / intervention
valganciclovir [Valcyte]drug
Likely dose
Not stated in 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.
Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
In Brief
A Phase 4 clinical trial evaluating valganciclovir [Valcyte] for Kidney Transplantation, Cytomegalovirus Infections. Completed, enrolled 57 participants across 25 sites in 9 countries.
Detailed Summary
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Brazil, France, Germany, Mexico, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartJul 2011
Primary CompletionMay 2013
TodayJul 2026
First PostedJun 20, 2011
Enrollment StartJul 31, 2011
Primary CompletionMay 31, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.0 years ago
Interventions
valganciclovir [Valcyte]drug
Oral, daily for up to 200 days.