Status:

TERMINATED

Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

Lead Sponsor:

Alexion Pharmaceuticals, Inc.

Conditions:

Antibody Mediated Rejection

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant req...

Detailed Description

The main objective of this study was to evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy prio...

Eligibility Criteria

Inclusion

  • Male or female patients ≥18 years old
  • Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation

Exclusion

  • ABO incompatible with living donor
  • Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient

Key Trial Info

Start Date :

November 2 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 13 2015

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT01399593

Start Date

November 2 2011

End Date

November 13 2015

Last Update

October 3 2017

Active Locations (41)

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Page 1 of 11 (41 locations)

1

Birmingham, Alabama, United States, 35294

2

La Jolla, California, United States, 92037

3

Los Angeles, California, United States, 90095

4

San Francisco, California, United States, 94143