Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248040
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2005-11-02
Brief Title:
Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation
Sponsor:
Dompé Farmaceutici SpA
Organization:
Dompé Farmaceutici SpA
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Parallel-group Pilot Study to Assess Efficacy Safety and Pharmacokinetics of 2 Schedules of Reparixin in the Prevention of Delayed Graft Function After Kidney Transplant in High Risk Patients
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None