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 range18 Years – 70 Years

SexALL

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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

What they're measuring

Donor-specific HLA Antibodies, Re-transplantation, or Death

Timeframe: 365 days

Trial details

NCT IDNCT03388008

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-31

Results submitted2021-10-09