At a glance
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Mechanisms of Belatacept (Nulojix) Effect on Alloimmunity and Antiviral Response After Kidney Transplantation - (BMS Study# IM 103-309)
In Brief
A Phase 4 clinical trial evaluating Belatacept for Renal Transplant Rejection. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This research evaluates the effectiveness of a new drug called belatacept (Nulojix) for the prevention of acute rejection and preservation of kidney function in transplant patients. Belatacept was approved in 2011 by the United States Food and Drug Administration (FDA) and is being marketed as Nulojix. The pharmaceutical company sponsoring this study is Bristol-Myers Squibb. Belatacept is a prescription medicine used in adults to prevent transplant rejection in people who have received a kidney transplant. Transplant rejection happens when the body's immune system senses that the new transplanted kidney is different or foreign, and attacks it. Belatacept is used with corticosteroids and certain other medicines to help prevent rejection of your new kidney. The purpose of the research is to understand whether the new drug, belatacept, is better than other anti-rejection drugs, such as cyclosporine and tacrolimus that are typically used in the treatment against kidney rejection in transplant patients.
Study Details
Timeline
Interventions
Subjects will receive intravenous belatacept at 5mg/kg every other week starting from day 1 and continuing with weeks 2, 4, 6, and 8, and then monthly at months 3, 4, 5, and 6. At month 6 patients may elect to continue for an additional six-month period of belatacept administration.