Status:
COMPLETED
Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Bristol-Myers Squibb
Conditions:
Lung Transplant Rejection
Antibody-mediated Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Lung transplantation is the ultimate treatment for patients with advanced lung disease. However, long-term outcomes remain disappointing and the median survival after transplantation is approximately ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03388008
Start Date
December 17 2019
End Date
August 31 2022
Last Update
November 25 2022
Active Locations (2)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
Houston Methodist Hospital
Houston, Texas, United States, 77030