Strategies to Improve Novel Drug Development in Kidney Transplantation Through the Clinical Trials Process.

Strategies to Improve Novel Drug Development in Kidney Transplantation Through the Clinical Trials Process. Clin Transpl. 2015;31:163-172 Authors: Jordan SC, Choi J, Vo A Abstract Kidney transplantation has emerged as the preferred treatment for end-stage renal disease. Despite excellent short-term outcomes with standard T-cell centric immunosuppression, long-term outcomes have not improved. Indeed, approximately 5,000 renal allografts fail in the United States each year. Until recently, the focus on causes for late graft failures was on calcineurin inhibitor toxicity and the effects of primary co-morbid conditions (i.e., diabetes and hypertension) or recurrent glomerular diseases. However, several recent studies have identified donor-specific antibodies and chronic antibody-mediated rejection as the primary causes of late allograft failures. This finding has resulted in a renaissance of interest in the development of new agents focused on modifying B cells and alloantibody responses. In 2015, the Food and Drug Administration (FDA) held a conference of experts focused on delineating a path forward for developing a more streamlined clinical trials process to obtain labeling for novel agents in transplantation. The particular focus was on developing new drugs to deal with desensitization and prevention and treatment of antibody-mediated rejection since there are currently no approved drugs in this area. In this manuscript, we will disc...
Source: Clinical Transplants - Category: Transplant Surgery Tags: Clin Transpl Source Type: research