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

NCT02145182 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2018-12-17

Study results available
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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

  • Delayed Graft Function

Interventions

DRUG

Eculizumab

Eculizumab is a complement component 5 inhibitor.

DRUG

Placebo

0.9% sodium chloride

Sponsors & Collaborators

  • CTI Clinical Trial and Consulting Services

    collaborator OTHER

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-21
Primary Completion
2016-11-22
Completion
2016-11-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145182 on ClinicalTrials.gov