Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dompé Farmaceutici S.p.A

Criteria

Inclusion Criteria:

• Male and female patients accepted and listed for renal transplantation due to end stage renal disease (ESRD)

• Planned isolated single kidney transplant from a non-living donor with brain death

• Recipients of a kidney maintained in cold storage

• Recipients at risk of developing DGF

• Planned induction with steroids + mycophenolate mofetil (MMF) or mycophenolic acid + biological induction

• Patient willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations

• Patient given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care

Exclusion Criteria:

• Recipients of an intended multiple organ transplant

• Recipients of a kidney from a living donor

• Recipients of a kidney from a non-heart beating donor

• Recipients of double kidney transplant

• Re-transplant >2

• Recipients of a kidney maintained by pulsatile machine perfusion

• Concurrent sepsis

• Recipients with hepatic dysfunction at the time of transplant

• Clinical contraindications to central line access, or arteriovenous fistula, if any, not suitable for infusion of investigational product

• Hypersensitivity to non steroidal anti-inflammatory drugs (NSAIDs)

• Patients simultaneously participating in any other clinical trials involving an investigational drug not yet authorized for use in kidney transplant

• Pregnant or breast-feeding women