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Reparixin in Prevention of Delayed Graft Dysfunction After Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by:
Dompé s.p.a.
ClinicalTrials.gov Identifier:
NCT00248040
First received: November 2, 2005
Last updated: June 7, 2011
Last verified: June 2011

November 2, 2005
June 7, 2011
October 2005
May 2008   (final data collection date for primary outcome measure)
Creatinine clearance (CrCl) in the immediate post-transplant period [ Time Frame: 1-3 and 10-12 hours post-reperfusion ] [ Designated as safety issue: No ]
Creatinine clearance (CrCl) in the immediate post-transplant period
Complete list of historical versions of study NCT00248040 on ClinicalTrials.gov Archive Site
  • Renal function tests [ Time Frame: daily up to day 7 post-transplant ] [ Designated as safety issue: No ]
  • Number of patients requiring dialysis within 7 days post-transplant [ Time Frame: up to day 7 post-transplant ] [ Designated as safety issue: No ]
  • Number of patients with immediate, slow and delayed graft function [ Time Frame: day 5 post-transplant ] [ Designated as safety issue: No ]
  • Acute rejection episodes [ Time Frame: month 6 and 12 post-transplant ] [ Designated as safety issue: No ]
  • Patient and graft survival rate [ Time Frame: month 6 and 12 post-transplant ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile [ Time Frame: day 1 and 2 of treatment ] [ Designated as safety issue: No ]
  • Standard laboratory tests and vital signs [ Time Frame: day -1 pre-transplant and day 7 post-transplant ] [ Designated as safety issue: Yes ]
  • Renal function tests
  • Number of patients requiring dialysis within 7 days post-transplant
  • Number of patients with immediate, slow and delayed graft function
  • Acute rejection episodes
  • Patient and graft survival rate
  • Pharmacokinetic profile
Not Provided
Not Provided
 
Reparixin in Prevention of Delayed Graft Dysfunction After Kidney Transplantation
A Phase 2, Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group (3 Arms) Pilot Study to Assess the Efficacy, the Safety and the Pharmacokinetics of Two Treatment Schedules of Reparixin in the Prevention of Delayed Graft Function After Kidney Transplantation 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.

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% have been reported, especially in recipients of kidneys from marginal donors. It is an important clinical complication as it requires dialysis, prolongs hospitalisation, raises the cost of transplantation, and makes more difficult the management of immunosuppressive therapy. Although the effects of DGF on long-term graft function are still debated, there is overall increasing evidence that DGF reduces long-term graft survival. Moreover, given the well documented impact of acute rejection on long-term graft survival, it is conceivable that DGF and acute rejection synergize in negatively influencing long-term graft survival. Kidney reperfusion, after long cold ischemia period, is associated with an inflammatory reaction characterized by massive polymorphonuclear leukocyte (PMN) infiltration both at the glomerular and tubular levels. The importance of CXCL8 in recruiting PMN in kidney tissue during the ischemic time and after reperfusion has been clearly documented.

The efficacy of reparixin in preventing PMN infiltration and tissue damage in rat models of kidney transplantation and lung transplantation, as well as the safety shown in human phase 1 studies, provide the rationale for a clinical study aimed at evaluating the effect of reparixin in preventing DGF after kidney transplantation

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Ischemia-Reperfusion Injury
  • Kidney Diseases
  • Drug: Reparixin continuous infusion
    Reparixin continuous infusion
  • Drug: reparixin intermittent infusion
    reparixin intermittent infusion
  • Other: placebo infusion
    placebo infusion
  • Experimental: reparixin continuous infusion
    Intervention: Drug: Reparixin continuous infusion
  • Experimental: reparixin intermittent infusion
    Intervention: Drug: reparixin intermittent infusion
  • Placebo Comparator: placebo infusion
    Intervention: Other: placebo infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy,   Spain
 
NCT00248040
REP0204
Not Provided
Dr. Marcello Allegretti/Research and Development Director, Dompé s.p.a.
Dompé s.p.a.
Not Provided
Not Provided
Dompé s.p.a.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP