EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection (NCT00105183) | Clinical Trial Compass
CompletedPhase 3
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
United States, Australia, Austria223 participantsStarted 2005-01
Plain-language summary
The purpose of this study is to assess the efficacy and safety of the study drug, known as "ATG Fresenius S," which is sometimes called "EZ-2053," to prevent a lung transplant patient's body from rejecting a transplanted lung or lungs.
Who can participate
Age range
18 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:
* Recipient of a primary single or double pulmonary allograft
* Capable of understanding the purposes and risks of the study and has given written informed consent, and agrees to comply with the study requirements
* Women of childbearing potential must have a negative serum pregnancy test within 4 days prior to randomization.
Exclusion Criteria:
* Undergoing second or living donor transplant
* Prior treatment with T-cell depleting agents within the previous 5 years for the purpose of immunosuppression
* Prior plasma exchange and/or treatment with IVIg within the past 5 years
* Pulmonary infection with pan-resistant Pseudomonas or any Burkholderia species
* Known positive blood cultures
* Donor lung ischemia time \> 8 hours for first lung and \> 8 hours for the second lung
* Previously received or is receiving a multi-organ transplant
* Pregnant women, nursing mothers or women of child-bearing potential who are unwilling to use reliable contraception. Effective contraception must be used BEFORE beginning study drug therapy, for the duration of the study and for 6 months following completion of the study
* Active, extra-pulmonary systemic infection requiring the prolonged or chronic use of antimicrobial agents or the presence of a chronic active hepatitis B or C
* Active liver disease (liver function tests greater than or equal to 2 times the upper limit of normal)
* Severe anemia (hemoglobin, \< 6 g/dL), leukopenia (WBC \< 2500/mm3), thrombocytopenia (pl…
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
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)