Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
NCT ID: NCT01567085
Last Updated: 2019-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2012-08-29
2017-05-24
Brief Summary
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To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Eculizumab
Eculizumab 1200 milligrams (mg) was administered intravenously (IV) over 25 to 45 minutes 1 hour prior to kidney allograft reperfusion.
Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days.
Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Eculizumab
Interventions
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Eculizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.
3. History of prior exposure to HLA (human leukocyte antigen):
* Prior solid organ or tissue allograft
* Pregnancy
* Blood transfusion
* Prior exposure to specific donor's HLA
Exclusion Criteria
2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
3. History of severe cardiac disease.
4. Prior splenectomy.
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Adelaide, , Australia
Camperdown, , Australia
Parkville, , Australia
Bordeaux, , France
Paris, , France
Paris, , France
Toulouse, , France
Tours, , France
Brescia, , Italy
Padua, , Italy
Barcelona, , Spain
Gothenburg, , Sweden
Uppsala, , Sweden
Cambridge, , United Kingdom
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2010-019631-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C10-002
Identifier Type: -
Identifier Source: org_study_id
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