At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 59 enrolled
Drug / intervention
Valganciclovirdrug
Likely dose
Valganciclovir 900 milligramsfrom 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 Multicenter Prospective Cohort Study to Investigate if Ganciclovir Significantly Affects Spermatogenesis in Adult Male Renal Transplant Recipients Receiving up to 200 Days Valganciclovir Vs. Concurrent Untreated Matched Controls
In Brief
A Phase 4 clinical trial evaluating Valganciclovir for Cytomegalovirus Infections. Completed, enrolled 59 participants across 19 sites in 2 countries.
Detailed Summary
This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls. Data will be collected from each participant for up to 52 weeks post transplant.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Infections
CountriesMexico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedAug 2012
Primary CompletionSep 2015
Study CompletionDec 2016
TodayJul 2026
First PostedAug 13, 2012
Enrollment StartJan 30, 2012
Primary CompletionSep 29, 2015
Study CompletionDec 30, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.9 years ago
Interventions
Valganciclovirdrug
Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.