Kidney IDEAs: the Future of Renal Replacement Therapy - Part 1
One of the things I love most about my advocacy work is attending meetings where cutting edge technologies in renal replacement therapies (RRT) are presented and discussed. While I think everyone can agree that there have been no dramatic advances in treatment for CKD and ESRD in the last 50 years or so, I truly believe, based on what I have seen recently, that we are on the verge of a transformation in the field of RRT. I also can’t help but notice striking similarities in some of the new technologies to many of the older, original dialyzers that began appearing in the last half of the century. In many ways it really is “back to the future”.
For a great overview of what the renal community is doing to advance treatment for CKD and ESRD, I recommend reading the Kidney Health Initiative (KHI) Technology Roadmap for Innovative Approaches to Renal Replacement Therapy. KHI, a public-private partnership between the American Society for Nephrology (ASN) and the U.S. Food and Drug Administration (FDA), was created in September 2012 to focus on promoting the development of safe and effective therapies for kidney disease and improving the lives of millions of kidney patients with end stage renal disease (ESRD). The resulting Roadmap is a catalyst for change and it intends to stimulate the innovation needed to move toward this goal. However, innovative RRT solutions must aim to achieve an improved patient quality of life.
The four high priority RRT research activities that the Roadmap focuses on are:
Portable and/or wearable kidneys
Biohybrid and or implantable kidneys
What follows are brief descriptions of current research in each area, and my observations from having personally seen various aspects of the research, either in person or presented by the researchers themselves.
First, let’s look at examples of enhanced dialysis, as this is perhaps the most likely area to see changes in the immediate future. Incremental improvements to existing dialysis therapies are long overdue. Simple changes, such as reducing equipment size, improving transportability, reducing volume and blood pressure shifts, and increasing treatment flexibility, could have a dramatic impact on patient quality of life.
Enhanced dialysis devices or interventions could be a self-contained PD device that weighs less than 10 pounds or a suitcase hemodialyzer that weighs less than 20 pounds, or a sleek dialyzer designed for simplicity of use, either in center or in the home, promoting patient self-care. Some examples of current technology that I have actually seen in the past year or so are:
The Dharma by EasyDial. This is an example of “back to the future”. While in Seattle recently, I had an opportunity to visit the NW Kidney Center’s Dialysis Museum. Imagine my surprise when I saw a portable suitcase kidney, developed by Dr. Eli Friedman and James T. Hutchisson in New York in 1976 (see photo). It is said that Philippine president Ferdinand Marcos secretly used a machine like this. Now, in 2018, there is Dharma, a unique, fully portable dialysis machine, which uses only 5 Liters of dialysate during each treatment, and looks like a sleek piece of carry-on luggage. I had an opportunity to see this dialyzer demonstrated in their lab in Irvine CA. Its Dialysate SMART Regeneration Technology allows for a completely mobile design that uses less than 5 liters of potable water in a compact suitcase on wheels weighing less than 20 lbs. Even more important is that early results are providing excellent clearance values in only a 2 hour treatment. I was hard pressed not to try to sneak one home with me!
Dialease. Fresenius Medical Care, is working with the Swiss engineering firm Debiotech SA to develop a portfolio of state-of-the-art peritoneal dialysis technologies to replace FMC’s aging Liberty cycler. Weighing in under 10 lbs, this machine is based on a novel cassette type system, integrating a simplified, reliable and precise mechanism into a miniaturized and easy to use cycler offering increased safety and comfort in the homecare setting.
Outset Medical’s Tablo. Tablo is a sleek, modern dialyzer that one could easily mistake for a piece of furniture. It was designed because their research showed that “people are happier when they are in control” and yet are denied that opportunity for competence in their dialysis treatments. It is truly a dialysis on demand device with an all-in-one dialysis solution: it makes clean water, produces dialysate, takes blood pressure, and delivers medication with no additional equipment to connect. No heavy bags of fluid to hang. There’s not even a hospital pole. BUT, and for many this is a big drawback, Tablo is not portable.
Leslie Trigg, CEO of Outset Medical, presented at the IDEA’s conference in Seattle last month, and stated that “CVD (cardiovascular disease) hit the innovation lottery, dialysis did not”. There are over 7000 medical device applications, and less than 10 are for RRT. Tablo is currently in clinical trials through 2019, in select dialysis clinics in the US, and an application for home use has been made.
Another area of research that is showing considerable progress in RRT is wearable HD or PD devices. These provide alternatives to stationary treatment options, allowing mobility during normal daily activities, and increased patient independence and freedom of movement (work, travel), as well as continuous or near continuous treatment, thus closely replicating normal kidney function.
WEAKID. The WEAKID project aims to validate a wearable/portable dialysis machine based on continuous flow peritoneal dialysis with a fluid access to the abdomen. Dialysate is continuously circulated and refreshed by means of a small and wearable unit that removes toxins, which improves PD clearance significantly—up to twice the current practice. This product is currently in human trials in Europe through 2019. I was at a meeting where the speaker describing this product said the results for the trials in Europe were favorable in all countries except France. The French were not impressed because, frankly, the “purse” was not chic enough. True story, and another example of why the patient voice is so important during research and development of RRT devices. https://www.youtube.com/watch?v=XcnM_g4Z46o
The WAK is being developed by Dr. Victor Gura of the Wearable Artificial Kidney Foundation and the Center for Dialysis Innovation at the University of Washington. The WAK is the first device to conduct an FDA-approved human trial of a miniaturized, wearable hemodialysis machine, based on dialysate-regenerating sorbent technology. The trial aimed to determine the efficacy of the wearable artificial kidney in achieving solute, electrolyte, and volume homeostasis in up to 10 subjects over 24 hours. Treatment with the WAK was well-tolerated and resulted in effective uremic solute clearance and maintenance of electrolyte and fluid homeostasis. These results serve as proof of concept that, after redesign to overcome observed technical problems, a wearable artificial kidney can be developed as a viable novel alternative dialysis technology. The first WAK, which underwent the trials, while successful in theory, was not realistic. Patients resembled suicide bombers (see the picture on the left), and so were reluctant to wear the device in public. However the current version 3.0 (pictured on the right) weighs in at a mere 2 pounds. “We have done three human trials already and have two more trials to go,” Gura said. “It has been a long 17 years we have been doing this, but I think we are beginning to see the beginning of the end.”