Phase 2
N=27
Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation
Lung Transplant Rejection · Antibody-mediated Rejection
Bottom Line
View on ClinicalTrials.gov: NCT03388008 ↗Enrolled (actual)
27
Serious AEs
74.1%
Results posted
Nov 2021
Primary outcome: Primary: Donor-specific HLA Antibodies, Re-transplantation, or Death — 0; 5; 3; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Belatacept (Drug); Tacrolimus (Drug); ATG (Drug); Mycophenolate Mofetil (Drug); Methylprednisolone (Drug); Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Donor-specific HLA Antibodies, Re-transplantation, or Death |
0; 5; 3; 3; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03388008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.