April 9, 2012
Wearable artificial kidney to be tested for safety and effectiveness in collaboration with FDA
A wearable artificial kidney, designed as a new treatment for kidney failure, will be tested in Seattle. The trial will be done in collaboration with the Food and Drug Administration under a new Innovations Pathway announced Monday.
The battery-powered wearable artificial kidney in its current form weighs about 10 pounds and is worn in a belt around the waist. Dr. Victor Gura, an associate clinical professor at the David Geffen School of Medicine, University of California, Los Angeles, invented the device. His goal is to free end-stage kidney disease patients from being tethered for several hours for three or more days a week to a dialysis machine. The hope is to improve the quality of life of these patients.
The Wearable Artificial Kidney is being developed by Blood Purification Technologies Inc. based in Beverly Hills, Calif..
The first United States trial of the Wearable Artificial Kidney will be conducted in Seattle in collaboration with Dr. Larry Kessler, professor and chair of the Department of Health Services in the University of Washington School of Public Health, and Dr. Jonathan Himmelfarb, professor of medicine, and director of the Kidney Research Institute at UW. In 2008, the Kidney Research Institute was established by the non-profit Northwest Kidney Centers and UW Medicine.
The FDA conceived the Innovations Pathway as a joining of forces between the federal regulatory agency and university researchers. The Innovations Pathway will try to expedite the pre-market evaluation of promising medical devices without sacrificing rigorous safety and effectiveness standards. The Wearable Artificial Kidney is one of three devices designed to improve the lives of people with end-stage renal disease that were selected from a total of 32 applications to pilot the new approach to product review. The national pool of applications came from small, start-up businesses as well as academic institutions. The researchers will work closely with the FDA at each step, from research protocol design through final analysis of results and application submittal for putting the product on the market. The collaboration is expected to align the trial with all the bases that must be covered to determine if the technology meets requirements for FDA approval.
Kessler said that the details of the trial and when it will start will be determined in conjunction with the FDA. While the plans are not yet established, he expects that patients in the study initially will wear the device under medical and nursing supervision in the hospital. If the device passes a number of checks, patients will likely then try wearing it on supervised visits away from the hospital.
The Wearable Artificial Kidney connects to a catheter to filter the blood of toxins and excess fluid. The hope of medical researchers is that such a device could, if necessary, operate around the clock, seven days a week like normal kidneys. The wearable artificial kidney has undergone preliminary tests with patients in Italy and the United Kingdom. Under the FDA Innovations Pathway, Gura and a team of medical and public health researchers at the University of Washington, in conjunction with Northwest Kidney Centers, will conduct the first US clinical trial of the Wearable Artificial Kidney.
“The design of the Wearable Artificial Kidney has been evolving for about a decade,” Himmelfarb said. The whole purpose of the project is to alleviate the plight of patients on dialysis.
Gura said, “Our dream is to give them a better and longer life.”
Gura also indicated that the collaboration with Kessler and Himmelfarb 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 project. Gura added that further trials will be conducted in several academic centers of excellence. The purpose, he said, is to harness the invaluable additional expertise from some of the best researchers in the field from around the country to make the Wearable Artificial Kidney available to the dialysis community.
Some of the many things Gura, Himmelfarb, Kessler and their fellow researchers might examine, depending on the trial plans formulated with the FDA, are the technical operations of the device, Its safety and effectiveness.
“Quality of life issues will likely be embedded in the trial design,” Himmelfarb said. “Well 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 cousins 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 cant just walk in,” he said. “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.”
Dialysis for end-stage renal disease for patients in the United States costs a total of $16 billion each year. Almost all of the costs are paid through Medicare or Medicaid or similar government programs. Living on dialysis often has unpleasant ups and downs in the way people feel. Patients in end-stage renal failure, even on regular dialysis, have a U.S. mortality rate of about 20 percent annually. There are not enough available donors to meet the great need for kidney transplants.
“Were looking for ways to improve the lives of these patients and foster better outcomes, and lower the costs of treatment,” Kessler said. That is a key reason why the FDA selected the testing of promising, innovative devices for the care of end-stage kidney diseases for the pilot testing of its Innovations Pathway. These technologies, Kessler said, are potential game-changers for the treatment of end-stage kidney disease.
The testing of the Wearable Artificial Kidney builds on Seattles history in saving the lives of people in end-stage kidney failure as well as exploring the boundaries of new technology. In the 1960s, the late UW Professor Dr. Belding Scribner and his team built a shunt that allowed such patients, who otherwise would have succumbed to their illness, to receive long-term kidney dialysis. His work paved the way for formation in 1962 of Northwest Kidney Centers in Seattle, the worlds first kidney dialysis organization.