drugset / Trial / NCT00321906
Comparison of Sirolimus and Azathioprine in Lung Transplantation
Phase 4
Completed
181 enrolled
University of Chicago
Astellas Pharma Inc · collabBaylor College of Medicine · collabColumbia University · collabLoyola University · collabOchsner Health System · collabUniversity of Florida · collabUniversity of Pennsylvania · collabUniversity of Wisconsin, Madison · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to compare the safety and effectiveness of two different anti-rejection drug regimens.
Timeline
- Start
- 2002-04
- Primary completion
- 2011-08
- Completion
- 2011-08
Publications
- Results Bhorade S, Ahya VN, Baz MA, Valentine VG, Arcasoy SM, Love RB, Seethamraju H, Alex CG, Bag R, Deoliveira NC, Husain A, Vigneswaran WT, Charbeneau J, Krishnan JA, Durazo-Arvizu R, Norwick L, Garrity E. Comparison of sirolimus with azathioprine in a tacrolimus-based immunosuppressive regimen in lung transplantation. Am J Respir Crit Care Med. 2011 Feb 1;183(3):379-87. doi: 10.1164/rccm.201005-0775OC. Epub 2010 Sep 10.
- Bhorade SM, Husain AN, Liao C, Li LC, Ahya VN, Baz MA, Valentine VG, Love RB, Seethamraju H, Alex CG, Bag R, DeOliveira NC, Vigneswaran WT, Garrity ER, Arcasoy SM. Interobserver variability in grading transbronchial lung biopsy specimens after lung transplantation. Chest. 2013 Jun;143(6):1717-1724. doi: 10.1378/chest.12-2107.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | 2 mg/kg | — |
| Comparator | Sirolimus | Small molecule | 2 mg | — |
| Comparator | Sirolimus | Small molecule | 4 mg | — |