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

This study has been terminated.
(Did not achieve statistical significance for primary endpoint)
Information provided by (Responsible Party):
Alexion Pharmaceuticals Identifier:
First received: July 19, 2011
Last updated: November 18, 2016
Last verified: November 2016
The purpose of this trial is to determine the safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring desensitization therapy.

Condition Intervention Phase
Antibody Mediated Rejection
Drug: Eculizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Living Donor Kidney Transplant Recipients Requiring Desensitization Therapy

Resource links provided by NLM:

Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • The primary composite endpoint is the Week 9 post-transplantation treatment failure rate defined as the occurrence of 1) biopsy-proven AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up. The diagnosis of AMR will be based on kidney allograft [ Time Frame: 12 months ]
    The primary analysis of all endpoints will occur after all patients have reached Month 12 post-transplantation.

Enrollment: 102
Study Start Date: September 2011
Study Completion Date: November 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eculizumab
IV administration over 35-45 minutes
Drug: Eculizumab
IV administered over 35-45 minutes
No Intervention: Standard of Care
Plasmapheresis and Intravenous Immune Globulin


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients ≥18 years old
  2. 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
  3. Able to understand the informed consent form and willing to comply with study procedures

Exclusion Criteria:

  1. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
  2. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01399593

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90095
San Francisco, California, United States, 94143
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Georgia
Atlanta, Georgia, United States, 30309
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Maryland
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New Jersey
Livingston, New Jersey, United States, 07039
United States, New York
New York, New York, United States, 10032
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
Houston, Texas, United States, 77030
Australia, South Australia
North Terrace, South Australia, Australia, 5000
Camperdown, Australia, 2050
Clayton VIC, Australia, 3168
Paris, France, 75010
Paris, France, 75743
Toulouse Cedex, France, 31059
Tours Cedex, France, 37044
Dresden, Germany, 01307
Heidelberg, Germany, 69120
Milan, Italy, 20162
Padova, Italy, 35128
Rotterdam, Netherlands, 3015 CE
Oslo, Norway, N-0027
Barcelona, Spain, 8036
Göteborg, Sweden, 413 45
Huddinge, Sweden, SE 141 86
Uppsala, Sweden, S 751 85
United Kingdom
London, England, United Kingdom, SE1 9RT
London, England, United Kingdom, W12 0HS
Oxford, England, United Kingdom, OX3 7LJ
Birmingham, United Kingdom, B15 2TH
Cambridge, United Kingdom, CB2 2QQ
Coventry, United Kingdom, CV2 2DX
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

Responsible Party: Alexion Pharmaceuticals Identifier: NCT01399593     History of Changes
Other Study ID Numbers: C10-001
2010-019630-28 ( EudraCT Number )
BB-IND: 100,003 ( Other Identifier: FDA IND: 100,003 )
Study First Received: July 19, 2011
Last Updated: November 18, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Alexion Pharmaceuticals:
Antibody Mediated Rejection
Acute Humoral Rejection
Living Donor
Kidney Transplant processed this record on March 28, 2017