At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 150 enrolled
Drug / intervention
ASP0113 +1 morebiological
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.
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
In Brief
A Phase 2 clinical trial evaluating ASP0113 and Placebo for Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients. Completed, enrolled 150 participants across 53 sites in 6 countries.
Detailed Summary
The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of ASP0113 in this patient population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, France, Germany, Spain, United States
CollaboratorsVical
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartNov 2013
Primary CompletionMay 2016
Study CompletionNov 2020
TodayJul 2026
First PostedNov 1, 2013
Enrollment StartNov 20, 2013
Primary CompletionMay 13, 2016
Study CompletionNov 5, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.7 years ago
Interventions
ASP0113biological
intramuscular injection
Placebodrug
intramuscular injection