Information on the Artificial Wearable Kidney

- Around 31 million Americans have chronic kidney disease. For patients with irreversible kidney problems, dialysis is a life-saving therapy. But it's also a tough treatment that requires a lot of time. Now, an artificial kidney may offer patients more freedom. Toby Munoz Jr. sits in a chair, three times a week for up to five long hours at a time. Munoz Jr. told Ivanhoe, “And it just drives me up the wall. I'm not a sit down person; I can barely make it through a movie at a theatre.” Toby needs dialysis to do the work of his failing kidneys. But the treatments have taken over his life, even forcing him to quit his job. Victor Gura, M.D., FASN, Associate Clinical Professor of Medicine of The Geffen School of Medicine at UCLA told Ivanhoe, “The quality of life of dialysis patients leaves a lot to be desired.”

Now researchers are studying a wearable artificial kidney. It does the same job as dialysis but it's portable, so it offers patients the ability to move while they receive therapy. Jonathan Himmelfarb, M.D., Director of the Kidney Research Institute at the University of Washington in Seattle, Washington says, “Live their life and move around not be tethered to a machine while receiving dialysis therapy.” The artificial kidney runs continuously on batteries and weighs 10 pounds. Researchers will study the device in up to 10 patients as part of a clinical trial. The goal is to give dialysis patients more freedom. “We hope to give them basically their life back” Dr. Gura explained. Toby says it would be a welcome change! This clinical trial will be the first human study in the U.S. conducted on the wearable artificial kidney. The researchers hope the device will allow patients to walk, shop, or perform other chores while receiving their treatments. They believe the portable device would also save money because patients will require fewer medications and hospital visits. While the current prototype weighs 10 pounds, they hope to make a smaller, lighter version soon. Contributors to this news report include: Cyndy McGrath, Supervising Producer; Marsha Hitchcock, Field Producer; Cortni Spearman, Assistant Producer; Rusty Reed, Videographer and Jamison Koczan, Editor. BACKGROUND: Kidney disease is the eighth leading cause of death in the United States and more than 10 percent of the U.S. population suffers from chronic kidney disease. Kidney disease is the gradual loss of the function of the kidneys. The kidneys filter waste and excess fluid from your blood which is then excreted through urination. Kidney disease is so dangerous because once it reaches an advanced stage, dangerous levels of fluids, electrolytes and wastes can build up in your body. The buildup of these wastes can cause symptoms such as nausea, vomiting, loss of appetite, fatigue or weakness, sleeping problems, changes in urine output, muscle twitches and cramps, swelling of feet and ankles, and a decrease in mental sharpness. Many of the signs and symptoms of kidney disease can be nonspecific and can also be caused by other illnesses. It is best to be checked by a doctor if you notice any signs or symptoms. (Source: http://www.mayoclinic.org/diseases-conditions/kidney-disease/basics/treatment/con-20026778, http://www.kidneyfund.org/about-us/assets/pdfs/akf-kidneydiseasestatistics-2012.pdf) TREATMENT: There are several treatments for chronic kidney disease. The correct treatment for you depends on the stage of the illness. Many treatments include: · High blood pressure medications · Cholesterol lowering medications · Anemia medications If your kidneys are not able to keep up with the waste and fluid clearance on their own, you may go into near or complete kidney failure. This is called end-stage kidney disease. Treatment for end stage kidney disease includes dialysis or a kidney transplant. Many patients with end-stage kidney disease are put on dialysis in order to remove waste products and extra fluid from the blood. A machine is able to filter waste and excess fluids from your blood and return the blood back into your body cleaned. The downside to dialysis is that it is a long process and requires patients to sit for many hours weekly while receiving treatment. (Source: http://www.mayoclinic.org/diseases-conditions/kidney-disease/basics/treatment/con-20026778) NEW TECHNOLOGY: A new wearable artificial kidney has been developed and is being tested in clinical trials. In essence, patients will be able to receive dialysis while on the go. The new artificial kidney machine will be wearable and will allow patients to have the freedom from traditional stationary dialysis machines. The wearable artificial kidney does the same job as regular dialysis machines just in a more physiological, or natural way. FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT: Victor Gura, MD, FASN 310-550-6240 victorgura@gmail.com If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at mthomas@ivanhoe.com Victor Gura, M.D., FASN, Associate Clinical Professor of Medicine at UCLA talks about a wearable artificial kidney that could give dialysis patients their freedom back. Interview conducted by Ivanhoe Broadcast News in November 2014. Dr. Gura: My endeavor has been for many years to come up with a better way of treating dialysis patients. Why is that so important to you? Dr. Gura: The plight, the suffering, the difficulties in life, the quality of life of dialysis patients leaves a lot to be desired. They have a very high mortality, they go to the hospital a lot, and they sit for untold hours in the machine. We have draconian impositions on their diet, they have to swallow a large amount of pills, and it's not a good life. Treating them forever, I felt we have to come up with a better way of doing that so that's why we're doing what we're doing. How will the wearable artificial kidney help them? Dr. Gura: We hope to give them basically their life back. We want to liberate them from the need of sitting on a chair hooked to a machine for untold hours. We want to reduce the amount of times they go to the hospital. We want to give them a better diet, we want to reduce the amount of complications, hospitalizations and last but not least we want to reduce the costs of dialyzing patients in the United States which is staggering and going up. How much is the cost? Dr. Gura: It's estimated that the U.S. tax payers spends about 30-billion dollars per year to keep patients alive with end stage renal disease. What would be the difference with the wearable kidney do you have any numbers with that? Dr. Gura: We have not had numbers because we never did it. But we would hope we have the potential to decrease the amount of medications, the amount of hospitalizations and several other things. This has yet to be proven, make no mistake, so we hypothesize that that's what will happen. And we have good reason to believe so but we still need to prove that of course. How does the wearable artificial kidney work? Dr. Gura: Well we had some challenges when we went to build a better device. If you want to afford the people mobility you have to give them freedom from being hooked to an electrical outlet; which means you have to have a device that works on batteries. We also had to find a way to give them a way to purify the water without the requirement of 40 gallons of fresh water per treatment, which is what we use today. That meant we had to basically find a mechanism to regenerate and cleanse the water so it could cleanse their blood, pick up the impurities, clean up the water and recycle it all the time. We were fortunate enough to achieve those two things. Make a small device that works on a battery and does not require 40 gallons of water. How much does it weigh? Dr. Gura: The present prototype, and this is simply a crude prototype, weighs about 11pounds. Given the resources that we need we would hope to make it much smaller and less voluminous. We have not accomplished that and it still needs to be done and it's just a matter of having the resources to accomplish that but it's do-able. What would this eliminate for patients, would it eliminate ever going back to the dialysis center or would it eliminate two trips out of three a week? D. Gura: I think I would be very cautious and say what it will eliminate. I would like to eliminate them having to go three or four times a week, sit by the machine for hours on end so they can go and do something else with their lives. I want to believe that we would eliminate a lot of the pills that they have to eat every day, what we call the pill burden which is humungous. Taking 20 pills a day, it's a big deal. It hurts your stomach and costs a lot of money. We would hope that we can give them a better diet where they can eat what they like. A dialysis patient would literally commit suicide by having a couple of glasses of orange juice and two bananas because their potassium would go up. We want to do away with that if we can. With this wearable device would you use it every day? Dr. Gura: Oh yes. People dialyze three times a week for 12 hours even if they are indicated that's not the way to do it. With your native kidneys, you don't take them off and put them on the nightstand, you use them 24/7. If we can make something that is small enough, miniaturized enough that can better mimic a native kidney then we would hope we can make this wearable 24/7. Make no mistakes I'm not making promises that in fact we'll achieve all that we have a lot to prove, but we're trying. Are you're starting a clinical trial? Dr. Gura: Oh yes, this is actually the third clinical trial ever done but the first in the United States and it's the first for 24 hours. We're very proud to do this in Seattle. The FDA approved the human use in the U.S. and supported us in this endeavor so this is what we're doing now. Is it a safety trial? Dr. Gura: Every trial in the eyes of the FDA has to prove two things, safety and efficacy. Until we have not proven that for good this will not be in the market. We have to satisfy criteria to prove that this is safe and efficient. As for your results, was your study overseas for this? Dr. Gura: The studies overseas were very preliminary and indicated preliminary data that this would be safe and efficient. But we're far yet from a definite proof. It would take several more trials and more work to get to that point. We're not there yet. If it all goes well, when could dialysis patients possibly see this? Dr. Gura: Patients are seeing it today as they were being treated. But if the question is when is this going to be available to the public, it would be too presumptuous for me to say now if and when because I don't have enough basis to support a clear date or a clear time. It's going to take a lot of work and it's going to take a lot of resources. We're working very hard to make that happen but I would not commit to a time line. You're very passionate about these patients what would it do to you to be able to get this to them? Dr. Gura: To me? Why would somebody go to medical school for any reason except because you want to alleviate pain and suffering or save lives. If you go to medical school that's what you want. And I would be basically fulfilling my endeavors and my hopes of becoming a physician. Alleviate suffering, make life better and hopefully save a few lives. This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.