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Sponsored by: |
Dompé pha.r.ma s.p.a. |
Information provided by: | Dompé pha.r.ma s.p.a. |
ClinicalTrials.gov Identifier: | NCT00248040 |
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.
Condition | Intervention | Phase |
Ischemia-Reperfusion Injury Kidney Diseases |
Drug: Reparixin |
Phase II |
MedlinePlus related topics: | Kidney Transplantation |
ChemIDplus related topics: | Reparixin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 72 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | June 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
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
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |||||
Transplant Center, University of Minnesota Medical School | |||||
Minneapolis, Minnesota, United States, 55455 | |||||
United States, Pennsylvania | |||||
Division of Transplantation, Drexel University College of Medicine | |||||
Philadelphia, Pennsylvania, United States, 19102 | |||||
France | |||||
Service de Transplantation et Soins Intensifs Nephrologiques, Hopital Necker | |||||
Paris, France, 75743 Cedex 15 | |||||
Service de Nephrologie et Transplantation, Hopital Lapeyronie, Centre Hospitalier Universitaire Montpellier | |||||
Montpellier, France, 34295 Cedex 5 | |||||
Italy | |||||
Divisione di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo | |||||
Bergamo, Italy, 24128 | |||||
Università degli Studi di Padova, Clinica Chirurgica III | |||||
Padova, Italy, 35128 | |||||
Divisione di Nefrologia e Dialisi, Azienda Ospedaliera Spedali Civili di Brescia | |||||
Brescia, Italy, 25123 | |||||
Spain | |||||
Division of Nephrology, Institut Catala de la Salut, Ciutat Sanitaria i Universitaria de Bellvitge | |||||
Barcelona, Spain, 08907 | |||||
Renal Transplant Unit, Hopital Clinic i Provincial de Barcelona | |||||
Barcelona, Spain, 08036 |
Dompé pha.r.ma s.p.a. |
Study ID Numbers: | REP0204 |
First Received: | November 2, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00248040 |
Health Authority: | United States: Food and Drug Administration |
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