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Patient Priorities

A Brighter Future: Improved Quality of Life for Those Receiving KRT

KRT strategies must focus on reducing mortality rates and prioritizing the needs of the patient. Patients identified nine key aspects of improved quality of life that KRT solutions must address.

Improved Quality of Life

Minimized impact/intrusion of therapy on family and social life
  • Patients receiving KRT often feel that they are unable to live a "normal life due to the disruptions of receiving treatment (e.g., frequency of treatments, fluid management, visibility of vascular access and/or equipment).
  • Family members often become care partners at home, which affects their own lives and schedules, changing the nature of their relationships.
Improved ability to work and travel
  • More than 60% of people living with kidney failure receive in-center conventional hemodialysis (HD).25 With each treatment lasting approximately 4 hours, it is challenging to accommodate a regular employment schedule. In the United States, more than 75% of patients are unemployed at the start of dialysis.26
  • Traveling can be difficult or impossible for people on dialysis; those receiving in-center HD must arrange for treatment at a facility at their destination, and those dependent on home dialysis must find a way to travel with devices that can weigh as much as 100 pounds.
Increased mobility and physical activity
  • Current KRT treatments can place limitations on patients' ability to be physically active:
    • While exercise is encouraged for people on dialysis, peritoneal dialysis (PD) patients must avoid getting their catheters wet or avoid applying any tension to them.
    • HD patients must avoid any effort that puts pressure or strain on their vascular access area, and anemia may cause activity-limiting weakness and fatigue.
Increased treatment choices
  • Even though people living with kidney failure are diverse, often at different stages of life with different lifestyles or daily requirements, they all have the same options among current KRT solutions (i.e., in-center HD, PD, home HD, transplantation)—options that have not substantially changed over the last 60 years. People living with kidney failure need more treatment options that not only improve their kidney function but also best fit their lifestyle and risk tolerance.
    • For example, a person living with kidney failure who must be employed may have challenges accommodating the consuming schedule of in-center HD treatments. This person could benefit from a more portable or continuous treatment option.
    • Collection of Patient Preference Information (PPI) could be used to identify subgroups of KRT recipients willing to accept greater risk for the benefit of near-term innovation in KRT.
Liberalized diet and fluid regulation
  • Most people receiving KRT must strictly limit consumption of sodium, potassium, and phosphorus. They also need to closely monitor and regulate their fluid intake to prevent excess fluid and waste from building up in their bodies. This regulation is critical for avoiding potential heart failure, bone disease, and changes in blood pressure but is restrictive to a person's diet and lifestyle.
Reduced medication burden
  • In addition to dialysis treatments and a restrictive diet, people living with kidney failure must also adhere to a regular medication regimen. One study found that those on dialysis take an average of 19 pills per day, both over-the-counter and prescription (e.g., phosphate binders, anti-hypertensive agents), to protect against treatment complications and compensate for side effects. The study also linked this high pill burden directly to a poorer health-related quality of life (HR-QOL).27
  • Those who receive a kidney transplant face a lifelong commitment to immunosuppressants, putting them at greater risk of infections and malignancies.
Reduced disease and treatment complications
  • While receiving treatment, additional complications such as fatigue, loss of appetite, nausea, vomiting, dizziness, infection, cramping, and pain of cannulation are common. This keeps people receiving KRT feeling sick and can lead to depression and feelings of hopelessness.
Reduced need for disease maintenance and interventions
  • People receiving KRT must often undergo repeated hospitalizations, readmissions, or other interventions while managing their disease and treatment.
    • In the United States, 80% of people receiving HD begin dialysis using a catheter for primary vascular access, with nearly 70% still employing a catheter 90 days later.28 This puts them at increased risk of infection, which is the second leading cause of death in people receiving dialysis.29
    • Catheters and other types of access (e.g., arteriovenous fistulas or grafts, needle insertions) can be painful or uncomfortable and often require multiple interventional procedures to maintain patency.
Reduced financial impact
  • Many of those receiving KRT in the United States have health care expenses related to their treatment that may not be covered by insurance (e.g., transportation to and from HD centers, over-the-counter medications). Others simply cannot afford their private insurance premiums.
  • In the United States, people receiving KRT who are not enrolled in Medicare Part D or covered by another prescription plan may find themselves paying large out-of-pocket sums for costly KRT medications.

Incorporating Patient Perspectives

Achieving this desired future state for people living with kidney failure is central to the roadmap strategy. KHI and the KRT community have committed to incorporating patient perspectives and preferences in designing and developing KRT innovations.

2017

  • Conducted a roadmapping workshop with 100+ community stakeholders, including people with kidney diseases, to review the state of the science and gain input on challenges and potential design criteria for alternatives to KRT

2018

  • Working groups and Patient Advisory Committee created to focus on patient-centered design criteria for mechanical, cellular, and vascular access components of KRT; published The Technology Roadmap for Innovative Approaches to Renal Replacement Therapy, together with a patient edition
  • Online survey of nearly 250 kidney failure and transplant patients to explore patient perceptions and treatment preferences and provide input on the benefits, downsides, and interest level in wearable and implantable devices
  • With input from patients, industry, regulatory, patient reported outcome (PRO) experts, and clinical representatives, KHI published a conceptual framework for incorporating PROs and patient perspectives into the product lifecycle.

2018-2019

  • Kidney Innovation Accelerator (KidneyX) launched as a public-private partnership between the US Department of Health and Human Services and the American Society of Nephrology; designed to be not only patient-centered but patient-driven throughout its governance structure and judging processes.
  • Began 3-year contract with FDA to pilot the ability to capture patient preference information (PPI); collected PPI from individuals with dialysis-dependent kidney failure to quantify the level of risk that patients are willing to accept in exchange for the benefits of a wearable KRT device.

2020

2021

  • Launched and awarded the First Phase of the Artificial Kidney Prize to accelerate the development of artificial kidneys toward human clinical trials. Prize winners included innovations that are wearable and others that are implantable as bioengineered and xenotransplant formats.
  • As a supplement to the KRT Roadmap, KHI launched an effort that will measure artificial kidney solution concepts against patient centered design criteria. These criteria are developed by identifying the problems and needs most important to people with kidney diseases and translating them into design criteria for product developers.