- * 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.
Antibody-mediated Rejection
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
NCT03221842 | PHASE 3 | INTERVENTIONAL
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).
Trial Information
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University of Alabama Hospital (at Birmingham)
Birmingham,Alabama,United States,35233
Mayo Clinic Arizona
Phoenix,Arizona,United States,85054
California Pacific
San Francisco,California,United States,94115
Yale New Haven Hospital
New Haven,Connecticut,United States,06520
University of Illinois Chicago
Chicago,Illinois,United States,60612
Brigham & Women's
Boston,Massachusetts,United States,02115
Mayo Clinic (Rochester)
Rochester,Minnesota,United States,55905
St. Barnabas Medical Center
Livingston,New Jersey,United States,07039
NYU
New York,New York,United States,10016
Columbia University
New York,New York,United States,10032
Vanderbilt University
Nashville,Tennessee,United States,37232
Houston Methodist
Houston,Texas,United States,77030
University of Wisconsin
Madison,Wisconsin,United States,53705
Universitair Ziekenhuis Gasthuisberg
Leuven,Belgium,3000
CHU de Bordeaux. Hpital Pellegrin
Bordeaux,France,33000
CHU de Grenoble Hpital Michalon
Grenoble,France,38043
Centre Regional Hospitalier Universitaire de Lille
Lille,France,59000
Hospital Edouard Herriot Lyon
Lyon,France,69003
Hopital saint Louis Paris
Paris,France,75010
Necker Hospital
Paris,France,75743
CHU Rangueil
Toulouse,France,31059
Charite Berline
Berlin,Germany,10117
Leiden University Medical Center
Leiden,Netherlands,2300
Hospital Universitari Vall d'Hebron
Barcelona,Spain,08035
Hospital Clinic de Barcelona
Barcelona,Spain,08036
Guy's Hospital
London,United Kingdom,SE19RT
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov