Comparison of Sirolimus and Azathioprine in Lung Transplantation

Completed · Phase 4

Conditions studied: Delayed Graft Function, Acute Graft Rejection

In brief

The purpose of this study is to compare the safety and effectiveness of two different anti-rejection drug regimens.

Key facts

Study ID

NCT00321906

Run by

University of Chicago

People needed

181

Starts

2002-04-01

Expected to finish

2011-08-01

Last updated by the study team

2016-09-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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