A Global Crisis
The global burden of kidney diseases is increasing, with chronic kidney disease (CKD) projected to become the fifth most common cause of years of life lost globally by 2040. With the chief risk factors—diabetes and hypertension—on the rise throughout the world, kidney diseases are a serious and under-recognized worldwide epidemic.
Chronic Kidney Disease* and Kidney Failure
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
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
Kidney Replacement Therapy (KRT)
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
- 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
- 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
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
- 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.
* In 2019, the KDIGO Nomenclature Consensus Conference undertook an effort to refine and revise the nomenclature used to describe kidney diseases. The resulting KDIGO consensus report recommends the use of "kidney" rather than "renal" or "nephro-" when referring to kidney diseases and kidney function, as well as the use of "kidney failure" rather than "end-stage kidney disease." The content of this site reflects these new nomenclature recommendations.