Trials / Completed
CompletedNCT02145182
Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)
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.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 288 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eculizumab | Eculizumab is a complement component 5 inhibitor. |
| DRUG | Placebo | 0.9% sodium chloride |
Timeline
- Start date
- 2014-08-21
- Primary completion
- 2016-11-22
- Completion
- 2016-11-22
- First posted
- 2014-05-22
- Last updated
- 2018-12-17
- Results posted
- 2018-12-17
Locations
78 sites across 9 countries: United States, Australia, Brazil, Canada, Czechia, France, Germany, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02145182. Inclusion in this directory is not an endorsement.