Status:
COMPLETED
Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation
Lead Sponsor:
Dompé Farmaceutici S.p.A
Conditions:
Ischemia-Reperfusion Injury
Kidney Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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, spe...
Detailed Description
Delayed graft function (DGF) is the most common allograft complication in the immediate kidney post-transplant period, affecting 25-35% of all patients who receive a cadaver graft, but rates up to 50%...
Eligibility Criteria
Inclusion
- 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00248040
Start Date
October 1 2005
End Date
June 1 2008
Last Update
January 10 2024
Active Locations (9)
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1
Transplant Center, University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
2
Division of Transplantation, Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
3
Service de Nephrologie et Transplantation, Hopital Lapeyronie, Centre Hospitalier Universitaire Montpellier
Montpellier, France, 34295 Cedex 5
4
Service de Transplantation et Soins Intensifs Nephrologiques, Hopital Necker
Paris, France, 75743 Cedex 15