Taking part in the 9th Annual Kidney Health Advocacy Day, advocates from the American Association of Kidney Patients (AAKP) and ASN are urging their congressional delegations to increase funding for kidney research at the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) to drive new breakthroughs for kidney patients and study the impact of COVID-19 on kidney health and people with kidney diseases.
Advocates from the American Association of Kidney Patients (AAKP) and ASN are calling on Congress to include funding for KidneyX in its annual government funding legislation and advance innovative technologies for kidney patients, such as a wearable or implantable artificial kidney.
Today, July 22nd, a virtual summit was hosted by KidneyX to announce the six winners of the Redesign Dialysis Phase 2 prize. The goal of the Redesign Dialysis prize is to provide prize money for novel ideas and innovations that will lead to better outcomes for people with kidney diseases and eventually to a truly artificial kidney. The eventual artificial kidney and innovations made along the way will lead to better outcomes for individuals with kidney diseases and improve their quality of life by bypassing in-center hemodialysis.
When a novel coronavirus emerged in late 2019, everyone risked infection, but kidney patients found themselves especially vulnerable. People with kidney disease have compromised immune systems and the vast majority of these individuals—roughly half a million people—must visit dialysis centers several times a week, exposing themselves to contact with staff and other patients when they should ideally be isolated at home.
Clinical trials often exclude people with kidney diseases. This means that 37 million people in the United States are rarely represented in the kind of research that advances change in treatment and care. The challenges that result from such exclusion are highlighted by the current COVID-19 crisis.
The Coronavirus – 2019 (COVID-19) pandemic is unmasking the shortcomings of in-center hemodialysis for people with kidney failure. Individuals with kidney failure who rely on in-center dialysis do not have the luxury of social distancing during a pandemic. In-center dialysis exposes people with kidney failure and healthcare workers to potential infection. Additionally, in-center hemodialysis patients are exposed to other discomforts and inconveniences associated with strict infection control and isolation policies necessitated by emergencies like pandemics.
The COVID-19 pandemic has brought new urgency to the need for alternatives to in center dialysis for people with kidney failure. Historically, integrating patient preferences into device development has been limited. Developments in the kidney community in recent years, including the KidneyX and the Advancing American Kidney Health initiative, have accelerated development of transformative devices for kidney replacement therapy.
The growing number of clinical trials the kidney community has enjoyed over the past few years is endangered due to the COVID-19 pandemic. Concerns over the safety of trial participants and investigators are paramount and are leading to rapid changes in the conduct of clinical trials.
The US Food and Drug Administration (FDA) released “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”, updated March 27, to provide clarity to the clinical trial community. Considering this guidance and after soliciting reactions from the clinical trial community, the Clinical Trials Transformation Initiative (CTTI) hosted a webinar on March 31 titled “Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID”.
The winners of the KidneyX Patient Innovator Challenge, funded by the National Kidney Foundation (NKF), were announced by Deputy Secretary of the U.S Department of Health and Human Services (HHS), Eric Hargan, on Thursday March 26 during NKF’s live-virtual 2020 Spring Clinical Meeting.
While there are many incentives to invest in rare diseases, well designed clinical trials are critical to getting the new therapies conceived by pharmaceutical companies to the people who need them.
Primary hyperoxaluria (PH) is a rare genetic kidney disease impacting fewer than 1000 people in the US. While many people with kidney disease are asymptomatic until they progress to kidney failure and can rely on dialysis or a transplant to replace their kidney function, the unique characteristics of PH cause severe symptoms early in life and make common kidney replacement therapies ineffective.