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Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224406
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : November 27, 2008
Sponsor:
Information provided by:
Dompé Farmaceutici S.p.A

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.

Condition or disease Intervention/treatment Phase
Ischemia-Reperfusion Injury Lung Transplantation Drug: repertaxin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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
Study Start Date : May 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. PaO2/inspired oxygen fraction ratio on ICU admission and at 24 hours after ICU admission

Secondary Outcome Measures :
  1. PGD score
  2. Time of mechanical ventilation
  3. Duration of ICU stay
  4. ICU mortality
  5. Acute rejection episodes
  6. Patient survival rate
  7. Pharmacokinetic profile


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients accepted and listed for transplantation due to irreversible, progressive disabling, end-stage pulmonary disease
  • Body weight 30 - 95 kg, inclusive (i.e. up to 95.99 kg)
  • Planned isolated (single and bi-lateral) lung transplant from a non-living donor with brain death
  • Normal renal function at the time of transplant
  • 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, including heart-lung and liver-lung transplantation
  • Recipients of a lung from a living lobar donor
  • Recipients of a lung from a non-heart beating donor
  • Re-do lung transplantation
  • Recipients requiring mechanical ventilation at the time of transplant
  • Recipients with extra-respiratory tract site of infection
  • Recipients with hepatic dysfunction at the time of transplant
  • Hypersensitivity to ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID)
  • Hypersensitivity to medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib
  • Patients simultaneously participating in any other studies involving a study drug to be administered concomitantly with the Investigational Product and/or a study drug intended to prevent ischemia/reperfusion injury
  • Planned use of anti-CD3 monoclonal antibody (Orthoclone OKT3) or alemtuzumab (Campath) induction immunosuppression
  • Planned use of sirolimus in the first three months after transplantation
  • Pregnant or breast-feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224406


Locations
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United States, California
University of South California, Department of Cardiothoracic Surgery
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado, Health Sciences Centre
Denver, Colorado, United States, 80262
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Dompé Farmaceutici S.p.A

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ClinicalTrials.gov Identifier: NCT00224406    
Other Study ID Numbers: REP0104
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: November 27, 2008
Last Verified: November 2008
Keywords provided by Dompé Farmaceutici S.p.A:
Lung transplantation
Reperfusion Injury
Survival
Additional relevant MeSH terms:
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Reperfusion Injury
Primary Graft Dysfunction
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications