According to the Centers for Disease Control and Prevention, or CDC, 37 million people in the United States are afflicted with CKD, representing an overall prevalence in the adult population of approximately 15%. For beneficiaries with CKD who do not have end-stage renal disease, or ESRD, annual fee for service, or FFS, Medicare expenses in 2019 totaled approximately $87.2 billion, representing 23% of total Medicare FFS spending. For patients with ESRD, total Medicare-related expenditures were $51.0 billion in 2019. ESRD is total and permanent kidney failure that is treated with kidney dialysis or with a kidney transplant. There are approximately 809,000 people in the United States living on kidney dialysis and approximately 135,000 new ESRD cases occur annually. According to the 2021 United States Renal Data System report, there were approximately 105,000 deaths from ESRD in 2019. There is a significant medical need to slow progression of kidney disease and reduce the number of patients progressing to kidney failure.

To help improve the diagnosis and management of kidney disease, the National Kidney Foundation, or NKF, has divided CKD into five stages. The severity of CKD at each stage is identified by the estimated glomerular filtration rate, or eGFR. Treatment during the first four stages of CKD focuses on ways to preserve kidney function for as long as possible. ESRD is the final stage of CKD in which the patient typically requires renal replacement therapy, i.e., dialysis or a kidney transplant, for survival.