Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation (NCT03388008) | Clinical Trial Compass
CompletedPhase 2
Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation
United States27 participantsStarted 2019-12-17
Plain-language summary
This is a pilot randomized controlled trial examining the feasibility of conducting a large scale randomized controlled trial of belatacept-based immunosuppression in lung transplantation. This pilot study will enroll 40 lung transplant recipients and randomize them to belatacept-based immunosuppression or standard of care. The primary endpoint of the study is the development of donor-specific HLA antibodies after transplantation. All study participants will be followed for a minimum of 12 months after transplantation.
Who can participate
Age range
18 Years – 70 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:
* Provided written informed consent for study participation
* Underwent single or bilateral lung transplantation
* Negative urine pregnancy test for women of child bearing potential and willingness to use highly-effective contraception
Exclusion Criteria:
* Requiring invasive mechanical ventilation immediately before transplantation
* Requiring extracorporeal life support (ECLS) (i.e., ECMO) immediately before transplantation
* Received treatment to deplete HLA antibodies before transplantation to improve the possibility of transplantation
* Having DSA immediately before transplantation (i.e., positive virtual crossmatch)
* Listed for multi-organ transplant (e.g., heart-lung, liver-lung, kidney-lung)
* Pregnant or breast-feeding
* Active infection with Hepatitis B or C virus
* Active infection with human immunodeficiency virus (HIV)
* Chronic infection with Burkholderia cepacia complex before transplantation
* Epstein Barr Virus (EBV) seronegative status
* Participation in another interventional clinical trial
* Allograft dysfunction requiring ECMO support after transplantation
* Delayed chest closure after transplantation
* Severe coagulopathy and significant bleeding in the opinion of the PI
* Any condition that in the opinion of the site PI introduces undue risk by participating in this study
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
Donor-specific HLA Antibodies, Re-transplantation, or Death