drugset / Trial / NCT02145182
Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)
Phase 2/3
Completed
288 enrolled
Alexion Pharmaceuticals, Inc.
CTI Clinical Trial and Consulting Services · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2014-08-21
- Primary completion
- 2016-11-22
- Completion
- 2016-11-22
Outcome
Missed primary endpoint
registry analysis (superiority test); Eculizumab vs Placebo; p = 0.3983; Odds Ratio (OR) 0.81 (95% CI 0.49 to 1.33); Regression, Logistic NCT02145182 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eculizumab | Monoclonal antibody | — | Intravenous |
Indications
No indication recorded.