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

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.