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Randomized, Double-blind, Placebo-controlled, Parallel-group Pilot Study to Assess Efficacy, Safety and Pharmacokinetics of 2 Schedules of Reparixin in the Prevention of Delayed Graft Function After Kidney Transplant in High Risk Patients
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.
Details
| Lead sponsor | Dompé Farmaceutici S.p.A |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 80 |
| Start date | 2005-10 |
| Completion | 2008-06 |
Conditions
- Ischemia-Reperfusion Injury
- Kidney Diseases
Interventions
- Reparixin continuous infusion
- reparixin intermittent infusion
- placebo infusion
Primary outcomes
- Creatinine Clearance (CrCl) in the Immediate Post-transplant Period — 1-3 and 10-12 hours post allograft reperfusion
CrCl was determined by two 60 minute urine collections, during the time intervals 1-3 and 10-12 hours of allograft reperfusion. Blood was withdrawn at the midpoint of each urine collection. CrCl at each timepoint was calculated according to the formula: creatinine clearance (mL/minutes) = urine creatinine (mmol/L) x urine volume (mL) / serum creatinine (mmol/L) x time of collection (minutes) An average was to be calculated from the two 60 minute values in each interval.
Countries
United States, France, Italy, Spain