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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/12/2018
Start Date:November 6, 2017
End Date:January 15, 2026
Contact:Clinical Trial Registration Coordinator
Email:clinicaltrials@cslbehring.com
Phone:610-878-4000

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A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the 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 in Adult Renal Transplant Recipients

This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant
patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase
inhibitor as add-on to standard of care (IVIG).


Inclusion Criteria:

- Male or female at least 18 years of age;

- 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:

- Recipient of an en bloc kidney transplant;

- 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.
We found this trial at
14
sites
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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1802 6th Avenue South
Birmingham, Alabama 35233
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Boston, Massachusetts 02115
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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Houston, Texas 77030
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Houston, TX
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Leuven,
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Livingston, New Jersey 07039
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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NYU
New York, New York
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2100 Webster Street
San Francisco, California 94115
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