Completed – Page 3 – Kidney Health Initiative (KHI)

Fostering Innovation in Fluid Management

Today’s innovators can change the status quo in fluid management for people with kidney failure. For people with kidney failure, a critical function of kidney replacement therapy (KRT) is maintaining volume balance through fluid management.

Technology Roadmap for Innovative Approaches to Renal Replacement Therapy

In October 2018, the Kidney Health Initiative (KHI) published The Technology Roadmap for Innovative Approaches to Kidney Replacement Therapy (KRT), which aimed to stimulate the innovation needed to move toward this goal.

Outcome Measures in Lupus Nephritis Trials

In partnership with the Lupus Nephritis Trial Network, a Kidney Health Initiative working group analyzed existing data to test for clear, valid endpoints for lupus nephritis trials. The

Regulatory Policies and Positions Affecting Device Approval in the US

There have been few innovative therapies marketed for patients with kidney diseases or kidney failure in the US in the last decade, while new therapies have been marketed in Europe and Canada years earlier. For medical device development, it is essential that device manufacturers and other stakeholders have optimal information regarding the standards and requirements for approval of clinical trial protocols and market approval for devices at the US Food and Drug Administration (FDA).

Prioritizing Symptoms of Kidney Failure Patients for Developing Therapeutic Interventions

While dialysis is a life-saving therapy for patients with end stage kidney disease (ESKD), a variety of symptoms occur following treatment that significantly diminishes the quality of life of people living with kidney disease. Patients have identified the need to alleviate these symptoms as a key research area, prioritizing it above other health outcomes.

Pragmatic Trials in Dialysis: Challenges and Opportunities

Defining the benefit of a therapy in routine clinical experience is an important opportunity for kidney diseases. Few randomized clinical trials have been conducted in this setting due to various perceived barriers – including US Food and Drug Administration (FDA) regulations related to data collection, lack of clarity around best practices for ensuring human subject protections, and cumbersome Centers for Medicare and Medicaid Services requirements related to billing for patients involved in research.

Pharmacokinetics in Patients Receiving Continuous Renal Replacement Therapy

Patients in the intensive care unit often develop acute kidney injury (AKI) and require continuous renal replacement therapy (CRRT), a procedure that differs significantly from outpatient dialysis. While the rate of acute kidney injury in the United States has doubled during the last 10 years, less than 20% of the drugs used have been studied with regard to appropriate dosing for patients in intensive care units (ICUs) receiving CRRT.

Advancing Technologies to Facilitate Remote Management of Patient Self-Care in Kidney Replacement Therapy

There is uncertainty regarding the approval of advanced medical devices, accessories, software, and mobile medical applications for consumer use. Reimbursement policies vary significantly across Medicaid, Medicare, and commercial insurance.