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

Use our guide to learn which trials are right for you!

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.
We found this trial at
5
sites
Baltimore, Maryland
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Heidelberg,
Click here to add this to my saved trials
Los Angeles, California
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Minneapolis, Minnesota
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials