Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dompé Farmaceutici S.p.A

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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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