Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation

Phase 2 Terminated 46 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb · collab Clinical Trials in Organ Transplantation · collab Rho Federal Systems Division, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the amount of other anti-rejection medications necessary and thereby reduce the long-term side effects caused by the other medications. The researchers also want to learn more about the safety of this treatment and long term health of transplanted pancreases and kidneys.

Timeline

Start: 2013-02
Primary completion: 2016-08
Completion: 2016-08

Publications

Results Stock PG, Mannon RB, Armstrong B, Watson N, Ikle D, Robien MA, Morrison Y, Odorico J, Fridell J, Mehta AK, Newell KA. Challenges of calcineurin inhibitor withdrawal following combined pancreas and kidney transplantation: Results of a prospective, randomized clinical trial. Am J Transplant. 2020 Jun;20(6):1668-1678. doi: 10.1111/ajt.15817. Epub 2020 Mar 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belatacept	Protein / enzyme biologic	—	—
Subject	Tacrolimus	Small molecule	—	—
Background	Methylprednisolone	Other / unclassified	—	—
Background	Mycophenolate Mofetil	Small molecule	1000 mg	Oral
Background	Mycophenolate Sodium	Unknown	720 mg	Oral
Background	Thymoglobulin	Protein / enzyme biologic	—	—

Indications

No indication recorded.