Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

December 17, 2019

Primary Completion Date

August 31, 2022

Study Completion Date

August 31, 2022

Conditions
Lung Transplant RejectionAntibody-mediated Rejection
Interventions
DRUG

Belatacept

Belatacept will be dosed at 10 mg/kg of actual body weight on days 0, 7, 14, 28, 56, and 84 then at 5 mg/kg on day 112 and every 28 days through day 364 (i.e., on days 140, 168, 196, 224, 252, 280, 308, 336, and 364)

DRUG

Tacrolimus

Tacrolimus will be dosed enterally or sublingually within 48 hours of transplantation and the dose will be adjusted to target a trough blood level of 8-15 ng/ml

DRUG

ATG

Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation

DRUG

Mycophenolate Mofetil

Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation

DRUG

Methylprednisolone

Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses

DRUG

Prednisone

Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365

Trial Locations (2)

63110

Washington University School of Medicine, St Louis

77030

Houston Methodist Hospital, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Washington University School of Medicine

OTHER