Clinical trials for the implantable artificial kidney haven’t started yet, but the device’s developers are already seeking feedback from patients. The device, currently in preclinical trials, uses microchip filters and living kidney cells that would be powered by a patient’s own heart. It is being developed by the Kidney Project, a collaboration between the University of California at San Francisco and Vanderbilt University. In March, they announced a partnership with Home Dailyzors United (HDU), who will help provide education and support to patients, as well as seek feedback on preferences.
“The Kidney Project is really interested in the patient voice, they want the patient perspective,” said Nieltje Gedney, vice president of HDU. She and HDU president Denise Eilers first met UCSF bioengineer Shuvo Roy, PhD, technical director of the project, at a Kidney Health Initiative meeting.
“When I first met them, I was struck by their passion for improving the outcomes of home dialysis patients,” said Roy. Working with them seemed like a natural move as they began looking for input from patients, he said.
“When we undertake any project, we are looking at the end result and the goal is quality of life, and this is what excited us the most,” said Eilers. “Shuvo and his team are dedicated to reaching those goals. And every step of the way they are committed to incorporating patient feedback, which is important because patients will be affected by this device the most.”
Roy said that they will seek patient feedback as they refine their designs, and get ready for clinical trials. “My hope is to have the HDU network of patients give us meaningful feedback that we can incorporate when we interact with the FDA for our clinical trials and beyond.”
Gedney said it’s important that researchers and developers know the risk benefits that patients will or won’t tolerate. “We’ve learned in the past, and the FDA has actually stressed this, that what the doctors and device developers might see as a benefit, is maybe not parallel to what the patients will tolerate for this benefit.”
It’s important, she said, to integrate patient feedback as early as possible in the research, to avoid wasting research dollars and time.
Roy said they are discussing putting together a survey to probe patients “in a scientifically meaningful way.” He said he hopes feedback from HDU will help them design a clinical trial that will give the most meaningful information in the fastest way possible.”
Roy said he hopes clinical trials for the implantable artificial kidney will start in 2018. The original plan was to start clinical trials at the end of 2017, which he said is looking less and less possible. They recently finished raising the funds to finish the preclinical studies, and are currently raises funds for the first human trial, which will just test the safety of the material. “We are hopeful. We are moving forward, maybe not in the same timeframe we had hoped for two years ago, but I’m hopeful we can still get it in early 2018.”
For more information on the development of the implantable artificial kidney, please visit the Kidney Project website.