A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2010
End Date:June 2013

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A Randomized Double-Blind Placebo-Controlled Pilot Study to Evaluate the Safety and Effect of CINRYZE® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-Mediated Rejection in Recipients of Donor-Sensitized Kidney Transplants

The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1
Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated
Rejection (AMR).


Inclusion Criteria include:

- ≥18 years of age.

- Weigh ≥50 kg.

- Donor specific antibody identified.

Exclusion Criteria include:

- Any surgical or medical condition that could interfere with the administration of
study drug or interpretation of study results.

- History of allergic reaction to C1 Esterase Inhibitor or other blood products.

- Participation in the active dosing phase of any other investigational drug study
within 30 days prior to dosing with study drug.

- Pregnancy or lactation.

- Receipt of any experimental agents for AMR within 1 month prior to the first dose of
study drug.

- Any infection that causes hemodynamic compromise.

- History of bleeding or clotting abnormality.
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