Status:
COMPLETED
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
Lead Sponsor:
Shire
Conditions:
Graft Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01147302
Start Date
August 24 2011
End Date
June 28 2013
Last Update
June 11 2021
Active Locations (5)
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1
ViroPharma Investigative Site
Los Angeles, California, United States
2
ViroPharma Investigative Site
Baltimore, Maryland, United States
3
ViroPharma Investigative Site
Minneapolis, Minnesota, United States
4
ViroPharma Investigative Site
Cincinnati, Ohio, United States