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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Antibody-mediated Rejection

In brief

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).

Key facts

Study ID

NCT03221842

Run by

CSL Behring

People needed

63

Starts

2017-11-06

Expected to finish

2021-01-20

Last updated by the study team

2022-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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