Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
Summary
The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 \[formerly interleukin (IL)-8\]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as the result of improved functional and clinical outcomes in lung transplantation patients. The safety of repertaxin in the specific clinical setting was also evaluated. The ability of repertaxin to reduce target cells (polymorphonuclear leukocyte \[PMN\]) infiltration into the graft was evaluated to confirm its mechanism of action.
Timeline
- Start
- 2005-05-01
- Primary completion
- 2006-09-13
- Completion
- 2007-09-13
Outcome
Missed primary endpoint
registry analysis (superiority test); Repertaxin (ITT) vs Placebo (ITT); p = 0.8541; Mean Difference (Final Values) 5.022; t-test, 1 sided NCT00224406 ↗
registry analysis (superiority test); Repertaxin (ITT) vs Placebo (ITT); p = 0.6996; Mean Difference (Final Values) 10.426; t-test, 1 sided NCT00224406 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Reparixin | Small molecule | 2.772 mg/kg | Intravenous |