CKD

Chronic kidney disease (CKD) is lasting damage to the kidneys that often worsens over time. It occurs when regular kidney function has decreased from Stage 1 (90% function) to Stage 5 (less than 15% function). Called a "silent disease," CKD often remains undetected until it reaches a later stage because many people exhibit no or few symptoms.

• Affects about 1 in 10 adults worldwide¹⁰
• Affects 14.9% of U.S. adults¹¹
• Only 10% of those at Stages 1-3 are aware of their CKD¹²
• Incidence and prevalence differ significantly across countries and world regions
  • People from disadvantaged populations may be at higher risk (and associated morbidity and mortality) due to additional social determinants of health.¹³

Kidney Failure

If CKD remains uncontrolled (and if the affected person survives cardiovascular or other complications), CKD may progress to kidney failure (i.e., estimated glomerular filtration rate (GFR) < 15 ml/min/1.73 m²). At this stage, kidney replacement therapy (KRT)—dialysis therapy or kidney transplantation—is required to remain alive.

• More than 110,000 Americans with kidney failure begin in-center hemodialysis treatment annually (2014-2018)¹⁴
• New patients diagnosed with kidney failure worldwide increases at a rate of 5-7% annually¹⁵
• Worldwide, many who require KRT do not receive treatment:
  • By 2030, it is estimated that 14.5 million people will need KRT, but only 5.4 million will receive it.¹⁶
  • Estimated that over 2 million people die each year due to limited access to KRT, most of whom live in low and lower-middle income countries¹⁷

Dialysis and Transplant

Transplantation remains the best treatment option, yet suitable organs are in short supply. Additionally, transplanted deceased donor kidneys remain functional for an average of 10-20 years and 15-20 years for a live donor kidney. Many patients require multiple transplants, often resulting in the return to dialysis treatment while awaiting another kidney.¹⁸

Most people living with kidney failure have little choice but lifestyle-limiting dialysis treatments, the side effects of which often leave them feeling sick and longing for a better quality of life. Dialysis was initially designed as a temporary treatment (i.e., it cannot replicate all kidney functions) rather than a long-term solution, but it remains the only viable option for many patients. In the United States alone:

• At the end of 2018, there were 783,925 patients with kidney failure, 554,038 (70.7%) undergoing dialysis and 229,887 (29.3%) with a functioning kidney transplant.¹⁹
• 50% of people on dialysis die within 5 years of beginning treatment²⁰
• 13 patients die each day waiting for a transplant.²¹
• People treated with dialysis have a life expectancy that is shorter than that associated with most cancers.²²

High Cost of KRT Care

Worldwide:

• Over 2 million people are living with kidney failure.
• The cost of dialysis and transplantation consumes 2%-3% of the annual health care budget but is spent on less than 0.03% of the total population in high-income countries.²³

United States:

• Total Medicare-related expenditures for beneficiaries with kidney failure rose to $49 billion in 2018.
• Medicare fee-for-service (FFS) spending for beneficiaries with CKD who did not have kidney failure exceeded $81 billion in 2018 and represented 22.3% of Medicare FFS spending.²⁴

KRT Innovation

Product development and innovation in the field of KRT had been moderate since the introduction of dialysis treatment over 60 years ago, despite:

• Unacceptably high morbidity and mortality rates
• High cardiovascular risk
• Infectious and hematologic complications
• Hospitalizations
• Poor quality of life

Similarly, despite some refinements in dialysis, innovation had been modest, especially when compared with the technological advancements in many other areas of medicine and society in general.