African Americans, Kidney Disease, and Drug Development: A Regulatory Perspective

Given the burden of kidney disease in African Americans, the discovery of safe and effective medical products to slow the progression of kidney disease and reduce the risk for kidney failure would have a tremendous impact on this population. Differences in response to treatment have been observed in African Americans, highlighting the importance of studying medical products in African Americans. Although historically the African American community has not been well represented in clinical trials, efforts are underway to address this issue. Recent advances in understanding the genetic contributions to disease progression in African Americans, including the discovery of risk variants in the apolipoprotein L1 gene (APOL1), raise the possibility of using genetic information to better tailor treatments for African Americans. One could envision developing therapies that target these variants or possibly using them to help enrich trial populations with patients more likely to experience disease progression.