Status:
COMPLETED
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
Lead Sponsor:
Dompé Farmaceutici S.p.A
Conditions:
Ischemia-Reperfusion Injury
Lung Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 \[formerly interleukin (IL)-8\]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as ...
Detailed Description
This was a phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel-group (two arms) study. A total of 100 patients accepted and listed for lung transplantation, who met all of t...
Eligibility Criteria
Inclusion
- Patients accepted and listed for transplantation due to irreversible, progressive disabling, end-stage pulmonary disease;
- Ages 18 to 65 years;
- Body weight 30 to 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. This included lobar lung transplant involving excision and sizing of a cadaver donor lobe to meet the thoracic dimension of the recipient before being transplanted;
- Normal renal function at the time of transplant as per calculated creatinine clearance (Clcr) 60 mL/min. Creatinine clearance was calculated according to the Cockcroft-Gault formula;
- Patient was willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations;
- Patient gave written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent could be withdrawn by the patient at any time without prejudice to their future medical care.
Exclusion
- 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 an extra-respiratory tract site of infection (positive blood culture(s) and/or fever associated with other signs of systemic sepsis syndrome). The criterion was not meant to exclude bacteraemic cystic fibrosis patients with or without fever, unless they presented with other signs of sepsis;
- Recipients with hepatic dysfunction (bilirubin exceeding 3 mg/dL and/or transaminases \>3X upper limit of normal \[ULN\]) at the time of transplant;
- Hypersensitivity to:
- Ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID);
- 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 anli-CD3 monoclonal antibody (Orthoclone OKT3) or alemtuzumab (Campath) induction immunosuppression;
- Planned use of sirolimus in the first 3 months after transplantation;
- Pregnant or breast-feeding women (NB: pregnancy was lo be avoided in patients or partners during the first month of participation in the study; no other specific warnings were described, considering even stricter general recommendations concerning pregnancy in transplanted patients, the treatment course of the investigational product, its pharmacokinetic profile, and the lack of significant adverse effects on mating performance and fertility in animal studies).
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2007
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00224406
Start Date
May 1 2005
End Date
September 13 2007
Last Update
December 11 2024
Active Locations (6)
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1
University of South California, Department of Cardiothoracic Surgery
Los Angeles, California, United States, 90033
2
University of Colorado, Health Sciences Centre
Denver, Colorado, United States, 80262
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
Duke University Medical Center
Durham, North Carolina, United States, 27710