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 |
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).
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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