Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309)

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.

Timeline

Start

2013-10

Primary completion

2021-04

Completion

2021-04-21

Publications

• Schaenman J, Rossetti M, Pickering H, Sunga G, Wilhalme H, Elashoff D, Zhang Q, Hickey M, Reddy U, Danovitch G, Reed EF, Bunnapradist S. Preservation of Antiviral Immunologic Efficacy Without Alloimmunity After Switch to Belatacept in Calcineurin Inhibitor-Intolerant Patients. Kidney Int Rep. 2022 Oct 20;8(1):126-140. doi: 10.1016/j.ekir.2022.10.015. eCollection 2023 Jan.

Drugs

Indications