Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation
Condition: Ischemia-Reperfusion Injury; Kidney Diseases
MeSH terms: Kidney Diseases; Reperfusion Injury; Ischemia; Delayed Graft Function
Intervention: Reparixin continuous infusion; reparixin intermittent infusion; placebo infusion
Intervention description: The Investigational Product was administered as an intravenous infusion into a (high flow) central vein or through an arterio-venous fistula, by an infusion pump adequate to provide reliable infusion rates, as per treatment schedule. Total infusion volume did not exceed 500 mL/24 hours. A dose of 2.772 mg/kg body weight/hour was to be administered for 12 hours. Placebo was volume/schedule matched saline.; A dose of 2.244 mg/kg body weight was to be administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were to be administered over a total period of 22.5 hours. Placebo was volume/schedule matched saline.; placebo was volume/schedule matched saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Kidney transplantation; Reperfusion Injury; Survival

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.
    

Eligibility 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