Study Stopped
Did not achieve statistical significance for primary endpoint
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
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
3 other identifiers
interventional
102
10 countries
41
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 requiring desensitization therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2011
Typical duration for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedStudy Start
First participant enrolled
November 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2015
CompletedResults Posted
Study results publicly available
April 19, 2017
CompletedOctober 3, 2017
September 1, 2017
2.5 years
July 19, 2011
March 9, 2017
September 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Failure Rate
The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.
9 weeks post-transplantation
Study Arms (2)
Eculizumab
EXPERIMENTALPatients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously: the median infusion time was 39 minutes.
Standard of Care
NO INTERVENTIONPatients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Atlanta, Georgia, 30309, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Baltimore, Maryland, 21205, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Livingston, New Jersey, 07039, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
North Terrace, South Australia, 5000, Australia
Unknown Facility
Camperdown, 2050, Australia
Unknown Facility
Clayton VIC, 3168, Australia
Unknown Facility
Parkville VIC, 3050, Australia
Unknown Facility
Paris, 75010, France
Unknown Facility
Paris, 75743, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Dresden, 01307, Germany
Unknown Facility
Heidelberg, 69120, Germany
Unknown Facility
Milan, 20162, Italy
Unknown Facility
Padua, 35128, Italy
Unknown Facility
Rotterdam, 3015 CE, Netherlands
Unknown Facility
Oslo, N-0027, Norway
Unknown Facility
Barcelona, 8036, Spain
Unknown Facility
Gothenburg, 413 45, Sweden
Unknown Facility
Huddinge, SE 141 86, Sweden
Unknown Facility
Uppsala, S 751 85, Sweden
Unknown Facility
London, England, SE1 9RT, United Kingdom
Unknown Facility
London, England, W12 0HS, United Kingdom
Unknown Facility
Oxford, England, OX3 7LJ, United Kingdom
Unknown Facility
Birmingham, B15 2TH, United Kingdom
Unknown Facility
Cambridge, CB2 2QQ, United Kingdom
Unknown Facility
Coventry, CV2 2DX, United Kingdom
Related Publications (1)
Marks WH, Mamode N, Montgomery RA, Stegall MD, Ratner LE, Cornell LD, Rowshani AT, Colvin RB, Dain B, Boice JA, Glotz D; C10-001 Study Group. Safety and efficacy of eculizumab in the prevention of antibody-mediated rejection in living-donor kidney transplant recipients requiring desensitization therapy: A randomized trial. Am J Transplant. 2019 Oct;19(10):2876-2888. doi: 10.1111/ajt.15364. Epub 2019 Apr 19.
PMID: 30887675DERIVED
MeSH Terms
Interventions
Limitations and Caveats
Data interpretation confounded by open-label study with potential reporting bias, unequal exposure to randomized prevention therapy between groups, some patients in SOC arm received eculizumab for treatment of AMR, all patients immunosuppressed.
Results Point of Contact
- Title
- Alexion Pharmaceuticals, Inc.
- Organization
- Alexion Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Masayo Ogawa, MD
Alexion Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2011
First Posted
July 22, 2011
Study Start
November 2, 2011
Primary Completion
May 13, 2014
Study Completion
November 13, 2015
Last Updated
October 3, 2017
Results First Posted
April 19, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share