drugset / Trial / NCT00248040

Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation

NCT00248040 ↗

Phase 2 Completed 80 enrolled Dompé Farmaceutici S.p.A
RandomizedParallel-groupDouble-blindPrevention

Summary

The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of reparixin in preventing the delayed graft function (DGF) after kidney transplantation.

Timeline

Start
2005-10
Primary completion
2008-05
Completion
2008-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Reparixin Continuous Infusion vs Placebo Continuous/Intermittent Infusion; p = 0.9076; Difference between means -0.275 (95% CI -5.00 to 4.45); Other NCT00248040 ↗

registry analysis (superiority test); Reparixin Intermittent Infusion vs Placebo Continuous/Intermittent Infusion; p = 0.3084; Difference between means 2.444 (95% CI -2.32 to 7.21); Other NCT00248040 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Reparixin Small molecule 2.244 mg/kg Intravenous
Subject Reparixin Small molecule 2.772 mg/kg Intravenous