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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

  Show 39 Study Locations
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 23, 2017