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

Abstract

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.

Diagnosis, Education, and Care of Patients with APOL1-Associated Nephropathy: A Delphi Consensus and Systematic Review

“…There is a pressing, unmet patient need for a specific, effective treatment for APOL1 -associated nephropathy (Table 1, statements C1 and C2). 60 The Consensus Group agreed that if a safe and effective treatment becomes available, all patients suspected of having APOL1 -associated nephropathy, including all Black patients with CKD, should be offered genetic testing and that treatment should begin as early as possible following a confirmatory kidney biopsy (Table 1, statements C3–C6). 12 Although an effective treatment has the potential to transform care for patients with APOL1 -associated nephropathy and reduce health disparities, uncertainties regarding insurance coverage, access to treatment, and inconsistency in clinical practice remain (Table 1, statements C7–C11 and C13).…”

Representation of Racial and Ethnic Minorities in Nephrology Clinical Trials: A Systematic Review and Meta-Analysis

“…Differential exposure to risk factors and differential access to care have been recognized, but differential responses to therapies based on the differences in social determinants of health, genetic, and epigenetic factors across populations with different demographics may also be important. [9][10][11][12][13] Representative enrollment of racial and ethnic minorities in nephrology trials is necessary to reduce disparities by ensuring that standard therapies are effective for all patients and that any differences in response are understood.…”