Comparison of Sirolimus and Azathioprine in Lung Transplantation

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborators: Astellas Pharma Inc; Baylor College of Medicine; Columbia University; Loyola University; Ochsner Health System; University of Florida; University of Pennsylvania; University of Wisconsin, Madison
• Treatments: Azathioprine; Everolimus; Prednisone; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.