Status:
COMPLETED
Comparison of Sirolimus and Azathioprine in Lung Transplantation
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Astellas Pharma Inc
Loyola University
Conditions:
Delayed Graft Function
Acute Graft Rejection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the safety and effectiveness of two different anti-rejection drug regimens.
Detailed Description
This multicenter prospective, randomized controlled clinical trial compared the open label use of sirolimus with that of azathioprine in a tacrolimus-based immunosuppression regimen. Eligible patients...
Eligibility Criteria
Inclusion
- Lung transplant recipients between the age of 18 and 65 years of age.
- Females who are capable of becoming pregnant must have a negative pregnancy test prior to consent. (Females of childbearing potential must be using a medically acceptable method of birth control for the duration of the study.)
- All patients must be able to give written informed consent.
Exclusion
- White blood cell count (WBC) \< 4.0/mm3
- Platelet count \< 100,000/mm3
- Severe hypercholesterolemia (\> 350 mg/dl) or hypertriglyceridemia (\> 500 mg/dl)
- Uncontrolled systemic infection at the time of consent.
- Previous organ transplant
- Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry or for the duration of the study (3 years).
- Use of maintenance immunosuppression other than daclizumab, tacrolimus, azathioprine, or prednisone prior to randomization.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00321906
Start Date
April 1 2002
End Date
August 1 2011
Last Update
September 21 2016
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637