drugset / Trial / NCT02145182

Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)

NCT02145182 ↗

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

EvaluationDrugModalityDoseRoute
Subject Eculizumab Monoclonal antibody — Intravenous

Indications

No indication recorded.