Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
NCT ID: NCT01399593
Last Updated: 2017-10-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
102 participants
INTERVENTIONAL
2011-11-02
2015-11-13
Brief Summary
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Detailed Description
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Patients were to be vaccinated against N. meningitidis at least 14 days prior to study drug initiation and revaccinated 30 days later. If not vaccinated 14 days prior, prophylactic antibiotics were to be administered. Pre-transplant infectious disease assessment was to be performed as part of the screening assessment.
Patients were to undergo desensitization therapy according to the practice of the local transplant center prior to transplantation, and this desensitization practice was to be uniformly applied for all patients at that center throughout the study. The actual length of desensitization for an individual patient was based on the clinical judgment of the Transplant Center team. Rituximab was prohibited in all patients as part of the pre-transplantation desensitization therapy due to potential pharmacodynamic interactions.
The control group was designed to test eculizumab against the best available care (referred to as standard of care, or SOC) consisting of plasmapheresis (PP) and/or intravenous immunoglobulin (IVIg). The best available care consisting of PP and IVIg was chosen because these modalities combined represented the most prevalent therapy reported in the literature and were the best available therapies at the time of this protocol's inception as per the transplant community.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Eculizumab
Patients 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.
Eculizumab
Standard of Care
Patients 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.
No interventions assigned to this group
Interventions
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Eculizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Masayo Ogawa, MD
Role: STUDY_DIRECTOR
Alexion Pharmaceuticals, Inc.
Locations
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Birmingham, Alabama, United States
La Jolla, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Livingston, New Jersey, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Houston, Texas, United States
North Terrace, South Australia, Australia
Camperdown, , Australia
Clayton VIC, , Australia
Parkville VIC, , Australia
Paris, , France
Paris, , France
Toulouse, , France
Tours, , France
Dresden, , Germany
Heidelberg, , Germany
Milan, , Italy
Padua, , Italy
Rotterdam, , Netherlands
Oslo, , Norway
Barcelona, , Spain
Gothenburg, , Sweden
Huddinge, , Sweden
Uppsala, , Sweden
London, England, United Kingdom
London, England, United Kingdom
Oxford, England, United Kingdom
Birmingham, , United Kingdom
Cambridge, , United Kingdom
Coventry, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2010-019630-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BB-IND: 100,003
Identifier Type: OTHER
Identifier Source: secondary_id
C10-001
Identifier Type: -
Identifier Source: org_study_id