At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 288 enrolled
Drug / intervention
Eculizumab +1 moredrug
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, Parallel-group, Double-blind, Placebo-controlled, Multi-center Study of Eculizumab for the Prevention of Delayed Graft Function After Kidney Transplantation in Adult Subjects at Increased Risk of Delayed Graft Function.
In Brief
A Phase 3 clinical trial evaluating Eculizumab and Placebo for Delayed Graft Function. Completed, enrolled 288 participants across 78 sites in 9 countries.
Detailed Summary
The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelayed Graft Function
CountriesAustralia, Brazil, Canada, Czechia, France, Germany, Italy, Spain, United States
CollaboratorsCTI Clinical Trial and Consulting Services
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartAug 2014
Primary CompletionNov 2016
TodayJul 2026
First PostedMay 22, 2014
Enrollment StartAug 21, 2014
Primary CompletionNov 22, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.1 years ago
Interventions
Eculizumabdrug
Eculizumab is a complement component 5 inhibitor.
Placebodrug
0.9% sodium chloride