Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
NCT ID: NCT03221842
Last Updated: 2022-07-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
63 participants
INTERVENTIONAL
2017-11-06
2021-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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C1-INH
C1-esterase inhibitor
C1-esterase inhibitor
C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution
Placebo
Excipients of C1-INH plus albumin
Placebo
Excipients of C1-INH plus albumin
Interventions
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C1-esterase inhibitor
C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution
Placebo
Excipients of C1-INH plus albumin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of at least one donor-specific antibody (DSA);
* Recipient of a kidney transplant;
* Achieved a steady-state, post-transplant eGFR ≥ 40 mL/min/1.73 m2 within 60 days of post-transplant OR a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days post-transplant in subjects with slow or delayed graft function;
* Acute AMR.
Exclusion Criteria
* Current active hepatitis C virus (HCV) infection;
* Active bacterial or fungal infection;
* Ongoing dialysis \>2 weeks;
* Known congenital bleeding or coagulopathy disorder;
* Current cancer or a history of cancer;
* Female subjects who are pregnant or breast feeding;
* Male or female subjects who are unwilling to use contraception or who are not surgically sterile.
18 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Program Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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University of Alabama Hospital (at Birmingham)
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
California Pacific
San Francisco, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Illinois Chicago
Chicago, Illinois, United States
Brigham & Women's
Boston, Massachusetts, United States
Mayo Clinic (Rochester)
Rochester, Minnesota, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
NYU
New York, New York, United States
Columbia University
New York, New York, United States
Vanderbilt University
Nashville, Tennessee, United States
Houston Methodist
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Universitair Ziekenhuis Gasthuisberg
Leuven, , Belgium
CHU de Bordeaux. Hôpital Pellegrin
Bordeaux, , France
CHU de Grenoble - Hôpital Michalon
Grenoble, , France
Centre Regional Hospitalier Universitaire de Lille
Lille, , France
Hospital Edouard Herriot Lyon
Lyon, , France
Hopital saint Louis Paris
Paris, , France
Necker Hospital
Paris, , France
CHU Rangueil
Toulouse, , France
Charite Berline
Berlin, , Germany
Leiden University Medical Center
Leiden, , Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Guy's Hospital
London, , United Kingdom
Countries
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References
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Viklicky O, Slatinska J, Novotny M, Hruba P. Developments in immunosuppression. Curr Opin Organ Transplant. 2021 Feb 1;26(1):91-96. doi: 10.1097/MOT.0000000000000844.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-000348-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL842_3001
Identifier Type: -
Identifier Source: org_study_id
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