Phase 4
N=181
Comparison of Sirolimus and Azathioprine in Lung Transplantation
Delayed Graft Function · Acute Graft Rejection
Bottom Line
View on ClinicalTrials.gov: NCT00321906 ↗Enrolled (actual)
181
Serious AEs
43.7%
Results posted
Feb 2014
Primary outcome: Primary: Acute Rejection Rate at 12 Months — 48; 39 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- azathioprine (Drug); sirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Rejection Rate at 12 Months |
48; 39 | — |
| SECONDARY Acute Rejection-free Survival at 12 Months |
56; 58 | — |
| SECONDARY Severity of Acute Rejection at 12 Months |
24; 18 | — |
| SECONDARY Bronchiolitis Obliterans Syndrome (BOS) at 24 Months |
81; 78 | — |
| SECONDARY Bronchiolitis Obliterans Syndrome (BOS) at 36 Months |
76; 72 | — |
| SECONDARY Overall Survival at 12 Months |
97; 97 | — |
| SECONDARY Overall Survival at 24 Months |
89; 94 | — |
| SECONDARY Overall Survival at 36 Months |
84; 87 | — |
Summary
The purpose of this study is to compare the safety and effectiveness of two different anti-rejection drug regimens.
Eligibility 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) 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.
Data sourced from ClinicalTrials.gov (NCT00321906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.