Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation

• Status: Active, not recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Bristol-Myers Squibb; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Abatacept; Methylprednisolone; Methylprednisolone Hemisuccinate; Mycophenolic Acid; Prednisone; Tacrolimus; Thymoglobulin

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