Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224406
Status:
COMPLETED
Last Update Posted:
2008-11-27
First Post:
2005-09-21
Brief Title:
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
Sponsor:
Dompé Farmaceutici SpA
Organization:
Dompé Farmaceutici SpA
Study Overview
Official Title:
A Phase 2 Multi-Center Randomized Double-Blind Placebo-Controlled Parallel-Group Study of Repertaxin in the Prevention of Primary Graft Dysfunction After Lung Transplantation
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 Repertaxin is a novel specific inhibitor of CXCL8 This study is configured to explore the safety and efficacy of repertaxin in preventing the primary graft dysfunction PGD after lung transplantation
Detailed Description:
Lung transplantation has become a standard therapy for patients with end-stage lung disease Within last decades donor management organ preservation immunosuppressive regimens and control of infectious complications have been substantially improved In addition the operative techniques of transplantation procedures have been developed to an international standard of high quality However despite these refinements significant reperfusion injury occurs in up to 10-20 of lung transplant recipients as the consequence of unavoidable processes of procurement preservation and restoring blood flow This clinical condition recently termed primary graft dysfunction PGD remains an important problem after lung transplantation and still represents the single biggest cause of early morbidity and mortality for lung recipients In addition there is some evidence to suggest a relationship between reperfusion injury acute rejection and the subsequent development of chronic graft dysfunction In post-ischemia reperfusion restoration of the blood supply reperfusion after prolonged tissue ischemia is associated with an inflammatory reaction characterized by massive polymorphonuclear neutrophil infiltration into the reperfused tissue The infiltrating inflammatory cells can perpetuate the initial inflammatory reaction and induce further injuries The importance of CXCL8 in lung tissue during the ischemic time and after reperfusion has been clearly demonstrated The current standard of care in preventing this clinical condition focuses on prevention by way of surgical techniques in the procurement storage and implantation of graft lungs The efficacy of repertaxin in preventing polymorphonuclear neutrophil 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 repertaxin in preventing PGD after lung 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