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wearable artificial kidney
The New Dawn of Dialysis
The UW—birthplace of home dialysis—unveils the next thing in fighting kidney failure

Jim and Eleanor Church’s Snohomish bedroom looks like the back room of a shoe store. Neatly stacked against one of the walls in their tidy 1990s rambler are dozens and dozens of brown boxes. But they don’t contain running shoes or high heels; instead, they hold gallons of peritoneal dialysis fluid that help remove waste products from Jim’s blood during home dialysis because his kidneys aren’t working very well. Jim is in good company.

At the end of 2011, more than 625,000 people were being treated for end-stage kidney disease in the U.S, according to the United States Renal Data System. Jim has been on dialysis of one kind or another for three years. The treatment of end-stage renal disease has been marked by a lack of progress. People with the condition have a relatively poor quality of life and a high mortality rate. The same options, peritoneal dialysis and hemodialysis, have been available for years. Innovation has been a long time coming in kidney dialysis—until now. At the UW, the birthplace of kidney dialysis, a clinical trial has been approved to test the safety and effectiveness of a wearable artificial kidney (WAK). Not counting preliminary studies, it is the first human trial of its kind in the United States. It is also the first human trial to win approval from the Food and Drug Administration (FDA)—and it will feature the longest use of the WAK.

The prototype for the wearable artificial kidney is familiar; it looks like a tool belt from a big-box hardware store. It is battery-powered, weighs about 10 pounds, can dialyze patients continually while allowing mobility, and it only takes a pint of fluid to work. Researchers are hoping the continuous dialysis the device provides will improve the quality of life for kidney patients and keep them healthier. They are also hoping the continuous process will help patients avoid dietary restrictions.

No matter what kind of dialysis people choose—treatment at a center or home dialysis—their life is restricted. The dialysis schedule dictates how they live, their activities and even when and if they can work. In many ways, Jim Church is a typical dialysis patient. He was diagnosed 20 years ago at age 59 with Type 2 diabetes. “I was surprised. I shouldn’t have been because my mother was a Type 2 diabetic. I was overweight and I also had high blood pressure,” he says in his soft Texas accent. (Both he and Eleanor grew up in Beaumont, Texas.) This is the common path to Type 2 diabetes: being overweight, developing diabetes and then, after some years, the kidneys begin to fail.

Jim Church

Dialysis patient Jim Church stores boxes of peritoneal dialysis fluid in his home so he can undergo home dialysis for 11 hours a day.

Karen Orders

He knew three years ago that something had to give. He and his wife had tickets to the Seattle Men’s Chorus holiday program. “I told Eleanor I couldn’t go because I was so tired, I couldn’t get from the parking garage to the concert. Very shortly after that, I started dialysis.”

Like many patients, he started off by going to a dialysis center. By the time he drove to and from the center, got hooked and unhooked from the machine, and then spent four hours dialyzing, it took a six-hour bite from his schedule three days a week.

“It was a hassle,” he says. “Then I started home dialysis.” During home dialysis, he has had several infections. Because the fluid drains unusually slowly from his body, Church has to dialyze for 11 hours each day. Once he starts the process, he’s confined to his bedroom where the dialysis machine sits next to his bed. If he has a Rotary meeting at 7 a.m., he has to start dialyzing by 7 p.m. the night before.

“When your body doesn’t work the way it’s supposed to, it has a significant effect on your activities,” says Eleanor. “The whole family is living with a chronic illness. He had peritonitis with peritoneal dialysis, but with hemodialysis, the blood pressure can plummet,” she says.

The WAK project was one of three proposals, out of 32 applications, chosen by the FDA to participate in its Innovation Pathway program. The FDA designed the Innovation Pathway to help safe, breakthrough medical products reach patients faster. The End-Stage Renal Disease Challenge, issued in 2012, focused specifically on innovative devices that address kidney failure, which is a growing public health care concern in the United States.

The WAK has been in development for more than a decade. Victor Gura, a physician specializing in internal medicine and kidney disease, created the initial WAK prototype in his Beverly Hills clinic. Gura originated the project at Cedars-Sinai Medical Center in Los Angeles and the David Geffen School of Medicine at UCLA. It has evolved to include the Kidney Research Institute, a collaboration between UW Medicine and Northwest Kidney Centers, as well as the Department of Health Services in the UW School of Public Health. Jonathan Himmelfarb, professor in the School of Medicine, and Larry Kessler, professor and chair of Health Services in the School of Public Health, are leading the study at the UW.

In the study at the UW, researchers will test up to 10 patients who will be monitored closely as they use the WAK for 24 hours at UW Medical Center. Then, the patients will be monitored for 28 days to see if the device is safe and effective. The FDA and the UW Institutional Review Board, which protects the interests of patients who are subjects in a trial, have approved the selection criteria.

Gura indicated that the collaboration with Kessler and Himmelfarb, one of the premier kidney researchers in the U.S., has been key in achieving the support of the FDA for the project as they bring a wealth of regulatory and research capabilities to the initiative. Gura adds that further trials will be conducted in several academic centers.

“Quality of life issues will likely be embedded in the trial design,” Himmelfarb says. “We’ll probably be asking patients, ‘Can you move with ease? How do you feel? How does the device or the treatment affect your daily life? Can you go to work with it on or go out with your family and friends?’ We will be looking at key health outcomes as well as health economics. At present, if you want to attend your cousin’s wedding in New York City, you need to check to be sure time slots are available at a center for you to get your dialysis done. You can’t just walk in,” says Himmelfarb. “If you live in a rural area, you probably drive a long distance every week for your dialysis sessions. A safe, effective, wearable artificial kidney would give end-stage kidney disease patients much more freedom in their lives.” Jim Church says that with proper planning he could have dialysis fluid delivered in Paris. “But, you are always thinking ‘what if it misses the flight and my stuff lands in Istanbul?’ With an artificial kidney you would be free from all of that,” he says.

Kessler says it’s important for people to realize that the WAK will not be for everyone. If a patient on dialysis was too frail he or she would not be a good candidate. Church is applying to be a candidate. Future trials are likely to involve multiple medical centers with patients spending more time away from medical facilities. Kessler says the next two big steps in engineering are to make the device lighter and more efficient.

It is fitting that the clinical trial of the latest innovation in end-stage renal treatment is taking place at the UW. In March 1960, the first shunt was implanted into the arm of machinist Clyde Shields and kidney dialysis successfully began. Belding Scribner, professor in the UW School of Medicine, developed the idea for U-shaped arteriovenous tubes that allowed blood to circulate from the patient’s body into a dialysis machine for cleansing of toxins. Tom McCormick, senior lecturer emeritus of bioethics, remembers Scribner telling him about the process.

“He had several young men with chronic kidney failure and all he could do was send them home to die. He went home and awakened in the middle of the night. He thought that if a patient had chronic failure they could send the blood through the kidney machine through the artery and the vein. The next morning, he took a drawing to work and the process started. I believe both he and Wayne Quinton experimented together bending Teflon tubing over a Bunsen burner, then plunging it into cold water so that it would hold its new shape.” Wayne Quinton was a truly imaginative engineer who ran the hospital’s Medical Instrument Shop. Quinton was experienced with Teflon and it was his skill that made the shunt workable. Once installed, the Scribner shunt allowed the treating team access to the blood supply at any time so that ongoing dialysis could be achieved.

David Dellinger, a UW surgeon, performed the procedure on March 9, 1960 as soon as the shunt was available. The original dialysis machine was as big as a washing machine. “Scribner told me he estimated there were 50,000 people who needed dialysis,” recalls McCormick. Thanks to dialysis, Shields went on to live another 11 years. The early work in dialysis by these medical innovators is considered to have kickstarted the modern era of medical bioethics.

Along with the new ability to dialyze patients came difficult ethical questions. For every four patients who needed dialysis, there was the capacity to treat one. The other three patients would die. A committee selected by the King County Medical Society worked anonymously and without pay to choose who would and wouldn’t receive dialysis. A dire situation drove the next innovation: The Committee denied treatment to a 16-year-old high school girl. Professor Albert Babb, UW professor of engineering, assembled a team of colleagues who worked on a portable dialysis machine called the Mini-1. It was delivered to UW Medical Center June 1, 1964 and thus the first portable dialysis unit was born. In 1972 the U.S. Congress voted to make dialysis a Medicare-eligible treatment.

Today the legacy of innovation in kidney care continues with the clinical trial of the wearable artificial kidney. If it’s safe and effective, it will doubtless have several iterations, making it smaller and easier to wear. Jim Church says he may not live to wear one, but he’s glad the UW is helping bring this possibility to the fore for the hundreds of thousands of patients whose lives are now restricted by current dialysis options.

­—Julie Garner is a Columns staff writer.

18 Responses to The New Dawn of Dialysis

  1. Yelena Khazatsky says:

    I’d like to have as much information on trial and when it’ll be came available.
    Thank you very much

  2. Vincent Dunn says:

    hello my name is Vincent and I’m a dialysis patient at NW Kidney centers in Seatac. I also still work full time and still drive. I would love to be a trial candidate for the portable kidney machine.
    Please have someone contact me to see if I’m qualified.
    206-747-4161 cell
    Vincent Dunn

  3. karina Hernandez says:

    Im intrested in human trials i live in coachella ca wish is 2 hrs away frm los angeles ca.. i been on dialisys for 9 yrs now i have high antibodies wish has been dificult to get a trasplant. I will like to try this… thnks

  4. james welsh says:

    i would never trust this and never wear something like that .i too active

  5. Mylam Thai says:

    Sounds very promising. I’ve been a hemodialysis patient for 2 years now. If you’re looking for candidates for trial, please send me the information so I can discuss it with my nephrologist. Thank you.

    Mylam

  6. Fabian Acosta says:

    Quality of life is the fundamental issue. Hope stems from the search that this article documents. For me, the question is fundamental, the balancing ongoing, the questions unafraid of answers however painful to accept – is the effort to live worth the result? We live in a society that is constrained by a 24 hour day. Of those 24 hours, I spend 2/3 of them struggling to make sure I am conforming to the care I have been told (and indeed do) need. Of the remaining time, I have at best maybe two hours of energy to deal with all the other needs of contemporary life for “the old”. There is NO question, my dialysis (12 hours a day), and the support of so many people, doctors, nurses provides me every day with precious time I value so highly, time when I can simply sit or walk and observe the richness of life. I ain’t happy but I have the happiness of a reasonable expectation that the quality of my life is improving (thanks entirely to those same people). I will always have to contend but in the truest sense who doesn’t. The advances in treating kidney failure dwarf my small needs yet my thanks to those people needs marking by me. They’re lucky, they’re doing good.

  7. Nan Johnson says:

    My Cousin in Canada has been on dialysis for 35 years and is so eagerly awaiting this wearable kidney when it is released.

  8. anjireddy says:

    Im intrested in human trials i live in coachella ca wish is 2 hrs away frm los angeles ca.. i been on dialisys for 3 yrs now i have high antibodies wish has been dificult to get a trasplant. I will like to try this… thnks
    Please have someone contact me to see if I’m qualified.
    919533335286 plz cell( india hyderabad)

  9. Mansur Arif Shamsi says:

    I just hope that it helps my father

  10. Tim says:

    since the device uses a catheter connection , are there plans to use other types of connection since the catheter type do not last long ? or does the patient have to have the catheter replaced frequently ?

  11. Prabal says:

    I am in India. My mother has to have dialysis twice a week. When will this device be available? Won’t it too late for many patients in developing countries?. I think I would die if it were to be available and my mother is not there to use it. Please develop it fast. IT IS THE NEED OF THE HOUR for all KIDNEY PATIENTS all over the world.

  12. Gregg Rice says:

    The WAK, Wearable Artificial Kidney, is one of a number of promising devices that are on the horizon to treat kidney failure. The University of California San Francisco is developing a fully implantable artificial kidney that, if successful, will replicate many of the functions of a biological kidney in addition to removing toxins from the blood. And of course, the patient will be untethered from a dialysis machine. Clinical trials are years off and there will many challenges to meet, but it could be a paradigm shift in the treatment of kidney failure.

  13. Mauro DeTrizio says:

    Please e-mail me any information on this device for a trial. My phone is: 201 863-3210 in NJ. Thank you.

  14. Hector galindo. says:

    Is a good idea I hope is gone to work good is going to be a blessing for many patients.

  15. Dr. Michael Ibadin says:

    I’m Doctor Micheal Ibadin,I am the representative doctor of University of Benin Teaching Hospital(UBTH),I have been given the opportunity by the hospital management to advertise on the internet how we operate,we are specialist in organ surgery and transplantation of human organs, we also deal in the buying and selling of human organs like kidney and liver,if you are interested to sell your kidney to us,you are advice to get back to us with the email below so that we can proceed further.
    you can check on the internet about our hospital for more information.
    Please get back to us with the below email:
    ubthospital.representative@gmail.com

  16. Keith Plescia says:

    I would like to be a test patient. I am 61 years old and have been doing home hemoiualysis for 1 year. I have experienced numbness and tingling in my feet that has gotten progressively worse since dialysis. My wife is a nurse and would be able to assist and monitor me. Please contact me at 201 290 8462 ASAP

  17. Barbara Skinner says:

    I have PKD. I am in good health except for kidney failure. I am interested in clinical trials for treatment.