Overcoming Barriers in Kidney Health—Forging a Platform for Innovation

Abstract

Innovation in kidney diseases is not commensurate with the effect of these diseases on human health and mortality or innovation in other key therapeutic areas. A primary cause of the dearth in innovation is that kidney diseases disproportionately affect a demographic that is largely disenfranchised, lacking sufficient advocacy, public attention, and funding. A secondary and likely consequent cause is that the existing infrastructure supporting nephrology research pales in comparison with those for other internal medicine specialties, especially cardiology and oncology. Citing such inequities, however, is not enough. Changing the status quo will require a coordinated effort to identify and redress the existing deficits. Specifically, these deficits relate to the need to further develop and improve the following: understanding of the disease mechanisms and pathophysiology, patient engagement and activism, clinical trial infrastructure, and investigational clinical trial designs as well as coordinated efforts among critical stakeholders. This paper identifies potential solutions to these barriers, some of which are already underway through the Kidney Health Initiative. The Kidney Health Initiative is unique and will serve as a current and future platform from which to overcome these barriers to innovation in nephrology.

Back to the Future: Glomerular Hyperfiltration and the Diabetic Kidney

“…Processes like fibrosis and inflammation undoubtedly contribute in major ways to the pathogenesis of DKD, but many attempts to translate these mechanisms to therapeutic targets have not yet succeeded (3–7). This consequence is likely due to a number of issues in the design and conduct of clinical trials, lack of validated DKD biomarkers, and barriers in the regulatory and business domains (8). …”

Translating Knowledge Into Therapy for Acute Kidney Injury

“…69 Integration of the complex multidimensional molecular and cellular data from the KPMP with clinical data and biomarkers will have to be performed in an open manner and formatted in such a way that it will support diverse analytic platforms at different institutions and companies. Parallel efforts will be required to develop new molecular classifications for patients with AKI, and to exploit the KPMP data sets to identify new predictive, prognostic, and pharmacodynamic biomarkers that can be used to define which subsets of patients are most likely to respond to specific therapeutic interventions.…”

The FDA and the State of Chronic Diseases: Cardiovascular, Endocrine, Pulmonary, and Renal Diseases

“…The American Society of Nephrology, the FDA, and >75 member organizations and companies established the Kidney Health Initiative (KHI), a public-private partnership seeking to enhance innovation and patient safety in kidney care. [48][49][50][51] In 2014, Medicare paid $26.1B to care for 428,000 hemodialysis patients. 52 However, the current 5-year survival rate for these patients is only 41.5%, significantly worse than most forms of cancer.…”