The Kidney Project wins KidneyX Award to enable simpler, safer at-home dialysis

A $500,000 KidneyX prize has been awarded to The Kidney Project—a collaboration between UC San Francisco and Vanderbilt University Medical Center (VUMC)—for the development of an implantable dialysis system called iHemo, which would enable patients to safely and effectively treat kidney failure at home.

KidneyX is a public–private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) to “accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases.”

The Kidney Project team, led by UCSF’s Shuvo Roy, PhD, and VUMC nephrologist William Fissell, MD, were among 15 winners of the KidneyX: Redesign Dialysis Phase 1 competition in 2019, and are now one of six winning teams in the competition’s second phase, announced July 22, 2020, in an online ceremony. In addition to the financial prize, the winning teams will work closely with leadership of the U.S. Food and Drug Administration (FDA), Medicare, and HHS to receive input on the technology as it advances toward commercialization.

“Our ultimate goal continues to be the elimination of all dialysis, by developing a fully functional, implantable bioartificial kidney,” said Roy, a faculty member in the Department of Bioengineering and Therapeutic Sciences, a joint department of the UCSF Schools of Pharmacy and Medicine. “But by catalyzing the development of iHemo, the KidneyX prize will allow us to adapt components of our implantable-kidney technology quickly for simple and safe dialysis treatment at home.”

Enabling more frequent, prolonged home dialysis could extend lives of patients awaiting transplant

Hemodialysis is the current standard of care for more than half a million patients with kidney failure in the United States, and the number of Americans in need of dialysis has been increasing every year. Three weekly visits to a dialysis center can extend a patient’s life for a few years while they endure the long wait for rare kidney transplants, but the half-century-old technique is both inefficient and increasingly expensive—estimated to account for about seven percent of Medicare’s annual budget. Finding better solutions for patients with advanced kidney disease has become an increasing national priority, as reflected in President Trump’s July 2019 Executive Order on Advancing American Kidney Health.

For the past decade, Roy and Fissell have been collaborating on the creation of a fully functional implantable bioartificial kidney. Their two-part design consists of a hemofilter capable of filtering out blood toxins through precisely patterned nanopore membranes—created using technology adapted from semiconductor manufacturing—as well as a bioreactor, containing living kidney cells, that performs other key kidney functions such as maintaining blood pH and hydration.

The complete bioartificial kidney is still some years away from being approved for clinical use, but its hemofilter component can be adapted into an implantable dialysis system that could allow patients to perform frequent and prolonged treatments in a safe and simple manner at home.

The proposed iHemo system connects an implanted hemofilter-like device to a patient’s circulatory system within their abdomen, then uses an external pump to infuse blood-cleansing dialysate through the device to filter blood toxins.

“Home dialysis has many advantages, but patients are put off by the equipment and the fear of needles and accidental bleeding,” Fissell said. “We’re going to provide the ability for patients to perform their own dialysis sessions at home at their convenience according to their schedules. By eliminating the blood and the needles and drain bags, we hope to get past the fear factor and reduce the footprint of the machinery.”

Prize moves iHemo device toward human trials

Since winning one of the first-round KidneyX prizes in 2019 for the iHemo concept, The Kidney Project research team has developed a prototype device and shown that its advanced nanofabricated materials can effectively filter blood in healthy pigs for up to 30 days without producing blood clots, even in the absence of systemic blood thinners.

The KidneyX Phase 2 prize will allow the team to scale up the device to be able to handle the blood volume needed for a clinically useful device in human patients and to demonstrate its effectiveness in pig models of kidney failure. Once these milestones are met, the team plans to launch a human clinical trial, which will also serve to demonstrate the efficacy of the technology for its eventual use as a component of a bioartificial kidney.

“We are delighted by this validation of our concept for using technological advances developed for the bioartificial kidney to improve the lives of dialysis patients,” Roy said. “We look forward to a future where people with kidney disease can lead more normal lives with iHemo, and ultimately with the implantable bioartificial kidney.”