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
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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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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1802 6th Avenue South
Birmingham, Alabama 35233
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Boston, Massachusetts 02115
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Houston, Texas 77030
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Leuven,
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Livingston, New Jersey 07039
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Livingston, NJ
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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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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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Nashville, TN
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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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