At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 65 years
- ✓Body weight 30 to 95 kg (inclusive)
- ✓Accepted and listed for transplantation due to irreversible, progressive disabling, end-stage pulmonary disease
- ✓Planned isolated (single and bi-lateral) lung transplant from a non-living donor with brain death, including lobar lung transplant
- ✕Recipients of intended multiple organ transplant, including heart-lung and liver-lung transplantation
- ✕Recipient of lung from a living lobar donor or non-heart beating donor
- ✕Re-do lung transplantation
- ✕Requiring mechanical ventilation at the time of transplant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Repertaxin in the Prevention of Primary Graft Dysfunction After Lung Transplantation
In Brief
A Phase 2 clinical trial evaluating Repertaxin and Placebo for Ischemia-Reperfusion Injury and Lung Transplantation. Completed, enrolled 114 participants across 6 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
An initial 'loading dose' of repertaxin was administered over 30 minutes by intravenous infusion followed by a maintenance dose lasting 47.5 hours.The infusion was to start approximately 2 hours prior to the anticipated time of reperfusion and was to continue during the ICU/hospital stay. The study medication was administered as a continuous intravenous infusion into a (high flow) central vein, by an infusion pump adequate to provide reliable infusion rates , as per treatment schedule. Total infusion volume was not to exceed 500 mL/24 hours.
An initial 'loading dose' of placebo was administered over 30 minutes by intravenous infusion followed by a maintenance dose lasting 47.5 hours.The infusion was to start approximately 2 hours prior to the anticipated time of reperfusion and was to continue during the ICU/hospital stay. The placebo was administered as a continuous intravenous infusion into a (high flow) central vein, by an infusion pump adequate to provide reliable infusion rates , as per treatment schedule. Total infusion volume was not to exceed 500 mL/24 hours.