Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)
NCT ID: NCT02145182
Last Updated: 2018-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
288 participants
INTERVENTIONAL
2014-08-21
2016-11-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Active
Eculizumab was administered by intravenous (IV) infusion over 25-45 minutes (min) for 2 doses (on the day of transplant then 18-24 hours \[h\] later).
Eculizumab
Eculizumab is a complement component 5 inhibitor.
Placebo
Placebo was administered by IV infusion over 25-45 min for 2 doses (on the day of transplant then 18-24 h later).
Placebo
0.9% sodium chloride
Interventions
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Eculizumab
Eculizumab is a complement component 5 inhibitor.
Placebo
0.9% sodium chloride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has dialysis-dependent renal failure (initiated more than 2 months prior to transplant)
* Participant is to receive a first kidney transplant from a standard criteria donor or expanded criteria donor deceased donor with a DGF risk score using the Irish scale of ≥25% (to be determined prior to surgery and before randomization)
* Able to provide written informed consent
* Willing and able to comply with the requirements of the study protocol
* Female participants of child-bearing potential must have a negative serum pregnancy test (serum beta-human chorionic gonadotropin) and must be practicing an effective, reliable, and medically approved contraceptive regimen at the time of consent and for up to 5 months following discontinuation of treatment
Exclusion Criteria
* Participant to receive kidney(s) from donors \<6 years of age
* Participant to receive a dual kidney transplant (from same donor, including en bloc)
* Participant to receive a living donor kidney
* Participant is highly sensitized (high risk to develop acute antibody-mediated rejection) to the donor (as determined by local center practice). Testing to determine high risk may include but is not limited to flow cytometric cross match, single antigen bead testing and/or complement dependent cytotoxicity
* Participant has received a previous transplant
* Participant is participating in another investigational study
* Participant has a body mass index \>40 kilograms/square meter at screening
* Participant will be the recipient of an A, B, O Blood Glycoproteins (ABO) (blood type) incompatible kidney (A2 donors to B and O recipients will be allowed if the site has the ability to confirm A2 subtype)
* Participant will receive a kidney from a donation after cardiac death donor
* Participant has a predicted Irish model risk of DGF \<25%
* Female participants who are pregnant or breast feeding
* Female participants of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
* Participants with a history of human immunodeficiency virus, or active hepatitis C virus or hepatitis B virus infection
* Participants with active bacterial or other infection which is clinically significant in the opinion of the Investigator
* Participants with a history of splenectomy
* Participants with unresolved meningococcal disease
* Participants with an unresolved systemic bacterial or fungal infection
* Participants with known or suspected hereditary complement deficiency (for example, but not limited to: atypical hemolytic uremic syndrome, paroxysmal nocturnal hemoglobinuria)
* Participant has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix that has been treated appropriately
* Participant has a history of or is believed by the Investigator to have used an illicit drug(s) and/or abused alcohol within 3 months prior to screening
* Participant has a psychiatric or physical illness that in the opinion of the Investigator would interfere with the ability of the participant to participate in the study
18 Years
ALL
No
Sponsors
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CTI Clinical Trial and Consulting Services
OTHER
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Francisco, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Livingston, New Jersey, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Winston-Salem, North Carolina, United States
Charleston, South Carolina, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Camperdown, New South Wales, Australia
Westmead, New South Wales, Australia
Adelaide, South Australia, Australia
Clayton, Victoria, Australia
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Prague, , Czechia
Bordeaux, , France
Créteil, , France
Le Kremlin-Bicêtre, , France
Lyon, , France
Nantes, , France
Paris, , France
Paris, , France
Strasbourg, , France
Suresnes, , France
Toulouse, , France
Tours, , France
Berlin, , Germany
Dresden, , Germany
Erlangen, , Germany
Essen, , Germany
Hamburg, , Germany
Hannoversch Münden, , Germany
Hanover, , Germany
Kiel, , Germany
Bari, , Italy
Brescia, , Italy
Milan, , Italy
Padua, , Italy
Torino, , Italy
Verona, , Italy
Badalona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Santander, , Spain
Seville, , Spain
Valencia, , Spain
Valencia, , Spain
Zaragoza, , Spain
Countries
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Other Identifiers
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2013-004650-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ECU-DGF-201
Identifier Type: -
Identifier Source: org_study_id