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A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant

NCT01403389 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-05-06

No results posted yet for this study

Summary

The purpose of this study is to determine if Eculizumab is safe and effective in the prevention of delayed graft function following deceased donor kidney transplantation.

Conditions

  • Delayed Function of Renal Transplant

Interventions

DRUG

Eculizumab

1200 milligrams Eculizumab diluted in 0.9% NaCl to 5mg/mL for a total volume of 240 mL administered by IV infusion over 35 minutes in the operating room prior to organ reperfusion

DRUG

Placebo

240 mL of 0.9% Sodium Chloride IV fluid given as placebo in the operating room prior to organ reperfusion

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Schroppel, Bernd, M.D.

    lead INDIV

Principal Investigators

  • Bernd Schroppel, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2013-08-06
Completion
2014-02-06

Countries

  • United States

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 NCT01403389 on ClinicalTrials.gov