Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation

Phase 2 Terminated 19 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trials in Organ Transplantation · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would minimize serious long term side effects associated with anti-rejection medications while still protecting the new kidney from damage. The researchers also wanted to learn more about the safety of this treatment and long term health of the transplanted kidney.

Timeline

Start: 2011-09
Primary completion: 2015-04
Completion: 2015-04

Publications

Results Newell KA, Mehta AK, Larsen CP, Stock PG, Farris AB, Mehta SG, Ikle D, Armstrong B, Morrison Y, Bridges N, Robien M, Mannon RB. Lessons Learned: Early Termination of a Randomized Trial of Calcineurin Inhibitor and Corticosteroid Avoidance Using Belatacept. Am J Transplant. 2017 Oct;17(10):2712-2719. doi: 10.1111/ajt.14377. Epub 2017 Jul 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alemtuzumab	Monoclonal antibody	—	Intravenous
Subject	Basiliximab	Monoclonal antibody	—	—
Subject	Belatacept	Protein / enzyme biologic	—	—
Comparator	Tacrolimus	Small molecule	—	—
Background	Methylprednisolone	Other / unclassified	—	—
Background	Mycophenolate Mofetil	Small molecule	1000 mg	Oral

Indications

No indication recorded.