Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation (NCT00224406) | Clinical Trial Compass
CompletedPhase 2
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
United States, Canada114 participantsStarted 2005-05-01
Plain-language 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 the result of improved functional and clinical outcomes in lung transplantation patients.
The safety of repertaxin in the specific clinical setting was also evaluated.
The ability of repertaxin to reduce target cells (polymorphonuclear leukocyte \[PMN\]) infiltration into the graft was evaluated to confirm its mechanism of action.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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prior to any study-related procedure not part of normal medical care, with the understanding that consent could be withdrawn by the patient at any time without prejudice to their future medical care.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 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 an extra-respiratory tract site of infection (positive blood cultur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PaO2/FiO2 Ratio at ICU Admission (Time 0) and 24 Hours
Timeframe: At T0 (time of ICU admission) and 24 hours post-ICU admission