Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

Phase 2 Terminated 71 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trials in Organ Transplantation · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of improving long-term graft function without increasing the risks of immunologic graft injury by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.

Timeline

Start: 2013-07
Primary completion: 2016-04
Completion: 2016-04

Outcome

Missed primary endpoint

Stopped: “Safety: Stopping rule not met.”

registry analysis (superiority test); Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac vs Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept; p = 0.544 NCT01856257 ↗

registry analysis (superiority test); Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac vs Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept; p = 0.531 NCT01856257 ↗

Publications

Results Mannon RB, Armstrong B, Stock PG, Mehta AK, Farris AB, Watson N, Morrison Y, Sarwal M, Sigdel T, Bridges N, Robien M, Newell KA, Larsen CP. Avoidance of CNI and steroids using belatacept-Results of the Clinical Trials in Organ Transplantation 16 trial. Am J Transplant. 2020 Dec;20(12):3599-3608. doi: 10.1111/ajt.16152. Epub 2020 Jul 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Basiliximab	Monoclonal antibody	20 mg	—
Subject	Belatacept	Protein / enzyme biologic	5 mg/kg	—
Subject	Methylprednisolone	Other / unclassified	500 mg	—
Subject	Tacrolimus	Small molecule	—	—
Subject	rabbit anti-thymocyte globulin	Protein / enzyme biologic	6 mg/kg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1000 mg	Oral

Indications

No indication recorded.