From University of Washington Medicine Newsroom
Contest award validates ideas for wearable kidney dialysis
A conceptual illustration of the wearable dialysis unit being developed by the CDI.
In 2014, Chuck Lee of Bothell, Washington, was among seven subjects in a clinical trial of a “Wearable Artificial Kidney.” The proof-of-concept dialysis device was an exciting idea for patients like Lee who have irreversible kidney failure and whose survival depends on thrice-weekly clinic visits to be tethered to a large blood-cleansing machine for four or five hours.
At 11 pounds, the prototype trial device was clunky, and it had technical challenges. But Lee loved it because it allowed him to consume tomato juice, Cheetos and other favorites long gone from his diet, and it gave him freedom to walk around the hospital unit as dialysis took place.
The device represented the first significant innovation for those patients since the 1960s, when the University of Washington pioneered dialysis as a life-sustaining therapy.
Eager to pursue the idea of wearable dialysis, the UW Center for Dialysis Innovation (CDI) launched in 2017. It’s composed of doctors and engineers who are rethinking the dialysis circuit and hoping to make wearable dialysis a reality for kidney-failure patients.
Today the CDI was honored as two of its ideas were chosen as finalists in the KidneyX Redesign Dialysis competition, a national contest. Contest sponsors are the U.S. Department of Health and Human Services and the American Society of Nephrology.
“We’re excited to be recognized. It was competitive – over 160 submissions, from which 16 were selected,” said Kassandra Thomson, who directs the CDI’s efforts to translate research into clinical practice. Today she is in Washington, DC, presenting concepts along with other contest honorees.
Today’s winners are invited to develop their ideas into prototypes and to compete in the second phase of the competition, in which up to three winners will be awarded $500,000 each next year.
Thomson described the CDI’s two submissions. One described the vision for a next-generation wearable dialyzer, depicted as a compact device that will allow patients to receive dialysis 24/7. It will be water-efficient, enable complication-free blood access, and more fully model kidney function. Mostly, the device would afford mobility and allow patients to live lives more fully.
The other submission is a new vascular access graft. Blood-vessel access has been called the Achilles’ heel of hemodialysis. Current vascular-access technologies have a finite lifespan; patients suffer repeated needle sticks and, after many repetitions, the points of access can fail and complications can ensue.
“The new arteriovenous (AV) graft we are designing will be resistant to repeated needle punctures, reduce blood clots that might form inside the graft, and induce blood vessels to grow into the graft, so that it becomes more like a piece of living tissue," Thomson said. “The goal is to dramatically improve outcomes and the patient experience with their vascular access, addressing unsolved problems that have plagued patients for decades."
Kidney disease has become a staggering health burden in the United States, affecting 40 million people. More than 700,000 of them have kidney failure, which means being on dialysis, getting a transplant, or dying.
“It’s time for the next big advance,” Thomson said, “and we want it to happen here.”
From healio.com
Innovators at KidneyX competition: Award winners look at access, hemodialysis process
Vascular access
Researchers/Developers: Mohammad R. Haider, PhD, and Steven D. Gardner
Department of electrical and computer engineering, The University of Alabama at Birmingham
Device: A non-invasive, wearable telehealth device to detect thrombosis and monitor the health of arteriovenous fistulas and grafts in patients on hemodialysis. It uses a small sensor to monitor the patient’s vascular access in real time and sends the acquired data to a local microcontroller for signal processing. A machine learning algorithm then classifies the input data to identify hemodialysis vascular access clotting and automatically alerts patients and their health care teams.
Researchers/Developers: Dimitri Augustin, MD
Stanford University Nephrology fellow and Stanford Biodesign alumnus
Racquel Redwood Meng
Stanford Biodesign alumnus
Device: A wearable, real-time monitor of arteriovenous fistula attributes that identifies failing or properly maturing arteriovenous fistulas. Patients will benefit from real-time arteriovenous fistula data immediately postoperatively without requiring significant time, skills of a health care professional or concurrent connection to a hemodialysis machine. When early arteriovenous fistula maturation failures are identified, providers will be notified in order to evaluate if early interventions are necessary.
Researchers/Developers: Access for Life Inc., Daniel Nadis, Roger Mason, MD
Device: This smart sensor-enhanced needle guide is implanted in the subcutaneous tissue. It directs a blunt needle through an opening in the skin to an underlying fistula, reducing pain from large bore needles. A biosensor on the JEM cylinder with an audio-visual alarm will reduce risks of back wall perforation and needle dislodgement. The sensors also measure blood flow, allowing nephrologists to identify increased stenosis risk.
Researchers/Developers: Yael Vin, MD, MPH, FACS; and Matthew Phaneuf
Beth Israel Deaconess Medical Center in Boston
BioSurfaces LLC in Ashland, Mass.
Device: Beth Israel and BioSurfaces LLC are developing a drug-eluting electrospun hemodialysis graft. “We have the technology to incorporate drugs that reduce neointimal hyperplasia into the electrospun fibers and localize this attachment to a certain segment (venous edge) and layers of choice (inner layer, mid layer),” the researchers wrote.
Hemodialysis
Researchers/Developers: Outset Medical Inc. in San Jose, Calif.
Device: The proposed innovation provides for an integrated, automated means of monitoring of important physiological parameters during hemodialysis, including blood volume status (absolute and relative), vascular access function (flow rate and circulation) and ultrafiltration rate. “This is especially impactful in care settings such as in-home or in-center self-care hemodialysis, where patients take on greater ownership of their therapy,” the researchers wrote.
Researchers/Developers: Christian Schafmeister, PhD
Department of chemistry, College of Science and Technology, Temple University
Device: Schafmeister and colleagues are developing atomically precise membranes for high-flux and selective removal of blood toxins during hemodialysis. “We propose a solution to the problem of replicating kidney functions by creating chemically synthesized, atomically precise membranes that can be as thin as a single-molecule that mimic the highly permeable and selective membrane channels present in human cells,” Schafmeister wrote. “ ... This will open the door for renal replacement therapy to personalized/precise medicine beyond simple dialysis.”
Researchers/Developers: Peter Kotanko, MD; Stephan Thijssen, MD; Xia Tao, MD, PhD;
and Vaibhav Maheshwari, PhD
Renal Research Institute LLC in New York
Device: Kotanko and colleagues are developing a device to improve the intradialytic removal of protein-bound uremic toxins using binding competitors. Hemodialysis can remove uremic toxins, but protein-bound uremic toxins are the most difficult, the researchers wrote. They are infusing a displacer substance into the dialysis machine’s blood tubing upstream of the artificial kidney. The displacer binds to the same binding sites on albumin as the toxins. “Thus, it quite effectively competes with the toxins for their albumin binding, displaces them from the albumin molecule, and, once they are free, they can then be easily removed in the artificial kidney,” wrote the researchers. “In laboratory experiments, we have seen up to a three-fold increase in the removal rate of these toxins.” The plan with KidneyX funding is to develop an ideal displacer (or a combination of displacers) that can be used routinely in hemodialysis and study the impact on toxin removal.
Researchers/Developers: Ira Kurtz, MD, David Geffen School of Medicine at University of California, Los Angeles
Roland Ludlow, CEO and founder, Curion Research Corporation
Jamie Hestekin, MD, professor, department of chemical engineering, University of Arkansas
Device: The group is developing dialysate- and cell-free renal replacement technology that would not require the use of an external dialysate solution to drive the flux of ions and water across a membrane. The device couples multiple wafer electro deionization technology with pressure-driven ultrafiltration, nanofiltration and reverse osmosis modules specifically developed for this project.
CKD
Researchers/Developers: Kirby Binayao, RN, MBA; Karl Quint, MD; and Karen Naranjo
Renal Tracker, the Netherlands
Device: Renal Tracker delivers new or existing CKD self-management programs via digital platforms and uses behavior change elements to help patients modify progression risks.
Home dialysis
Researchers/Developers: Janelle Kaneda, Alisha Birk and Mark Buckup
Bioengineering department, Stanford University
Device: This device utilizes optical interrogation methods for early diagnosis of peritonitis.
The OpticLine will use spectrophotometry to analyze the optical density of whole blood counts (WBCs) in the dialysis waste fluid to gauge for infection. With a prototype, various WBC concentrations in Dulbecco’s phosphate-buffered saline were measured. “Our results from our works-like spectrophotometer prototype experiment indicate that we detect a significant difference in optical density between our two WBC concentrations of interest: 10 WBC/mm3 (normal) and 1,000 WBC/mm3 (infected) (P value = 1.47E-07),” the researchers wrote.
Infection control
Researchers/Developers: Alexander Yevzlin, MD
Director of interventional nephrology, division of nephrology
University of Michigan in Ann Arbor
Device: This is a nitric oxide-eluting, disposable hemodialysis catheter insert aimed at preventing infection and thrombosis. Nitric oxide (NO) is an endogenously formed gaseous molecule that is well known to play a key role in preventing infection and thrombosis. The disposable NO release insert will be replaced at each dialysis session (every 2 to 3 days).
Artificial kidney
Researchers/Developers: Shuvo Roy, PhD; William H. Fissell, MD; and Charles Blaha, MS
University of California, San Francisco; Vanderbilt University Medical Center in Nashville;
Silicon Kidney
Device: The researchers are developing a hemodialysis system (iHemo) that involves implanting a compact hemodialyzer (HemoCartridge) that creates a permanent internal vascular connection. “The iHemo will improve dialysis patient outcomes and their quality of life by eliminating risk of accidental blood disconnect and encouraging frequent and prolonged hemodialysis treatments, especially within the home setting,” they wrote.
Researchers/Developers: Jonathan Himmelfarb, MD; Buddy Ratner, PhD; Larry Kessler, ScD; Kassandra Thomson, PhD; Glenda V. Roberts; and Anna Galperin, PhD
University of Washington Center for Dialysis Innovation in Seattle
Device: The UW Center for Dialysis Innovation is developing the Ambulatory Kidney to Improve Vitality (AKTIV): a wearable, miniaturized dialysis system that “is low-cost, water-efficient, requires minimal anticoagulation, offers complication-free blood access and is patient-friendly,” the researchers wrote. “The AKTIV will provide sustained life, and higher quality, more productive lives for patients worldwide, allowing almost unlimited mobility, dramatically reduce pharmaceutical burden and reduce dietary restrictions.”
Researchers/Developers: Qidni Labs Inc.
Device: This is a project to develop an automatic air removal system that can be used safely in a wearable renal therapy device with minimal user intervention. This system uses an air removal filter of the design used in cardiopulmonary bypass and extracorporeal membrane oxygenation systems. This system can also determine and signal the patient with an alarm if the hydrophobic isolation filter element has been wetted and thus has reduced the accuracy of the integrated return blood pressure monitor.
Transplantation
Researchers/Developers: Jeff Ross; Joseph Uzarski
Miromatrix Medical Inc., Eden Prairie, Minn.
Device: Using multiple patented technologies, Miromatrix is working to bioengineer new kidney grafts that consist of human cells grown in pig extracellular matrix scaffolds. “Perfusion decellularization removes the native cells from pig kidneys while leaving behind a transplantable scaffold that provides the framework needed to grow a new kidney graft,” the developers wrote. Miromatrix’s perfusion software drives cells to regenerate kidney structures, including blood vessels and nephrons, in laboratory bioreactors. As an initial step, Miromatrix has developed a process to revascularize kidney grafts with consistent performance in vivo. Revascularized kidney grafts have shown sustained vascular patency on follow-up angiographies in chronic pig transplantation models without evidence of blood clotting.
Reference:
www.kidneyx.org/WhatWeDo/PrizeCompetitions/redesigndialysisphasei
PKD Research
From MD Linx
Octreotide-LAR in later-stage autosomal dominant polycystic kidney disease (ALADIN 2): A randomized, double-blind, placebo-controlled, multicenter trial
In this randomized and placebo-controlled trial, researchers assessed the renoprotective effect of octreotide long-acting release (octreotide-LAR) in autosomal dominant polycystic kidney disease (ADPKD), the most frequent genetically determined renal disease, patients at high risk of ESRD due to later-stage ADPKD. For this investigation, 100 patients with estimated glomerular filtration rate (GFR) 15–40 ml/min/1.73 m2 were randomized to receive two 20-mg intramuscular injections of octreotide-LAR (n = 51) or sodium chloride (placebo; n = 49) every 28 days for 3 years. Investigators found that 3-year octreotide-LAR treatment did not significantly affect the decline in GFR vs placebo, but significantly slowed cyst growth and progression to end-stage kidney failure, especially in patients with more severe kidney failure (stage 4) to begin with, and was safe and well tolerated. Overall, the authors concluded that octreotide-LAR was well tolerated and during the study, there was no patient requiring interruption of treatment or even transient dose down-titration
Living with PKD
From JD Supra
Remedy Intelligent Staffing and Lornamead to Pay $50,000 to Settle EEOC Disability Discrimination Suit
Living with PKD
From JD Supra
Remedy Intelligent Staffing and Lornamead to Pay $50,000 to Settle EEOC Disability Discrimination Suit
Staffing Agency and Manufacturer Failed to Accommodate and Instead Fired Long-Term Temporary Worker With Kidney Condition, Agency Charged
BUFFALO, N.Y. - Remedy Intelligent Staffing, LLC, a California-based staffing firm, and Lornamead, Inc., a manufacturer headquartered in New York City, will pay $50,000 and furnish other relief to settle a disability discrimination lawsuit filed by the U.S. Equal Employment Opportunity Commission (EEOC), the federal agency announced today. The EEOC charged that Remedy and Lornamead violated federal law when they refused to provide a reasonable accommodation to a long-term temporary employee that would have enabled him to continue to work after his kidney condition worsened, and instead ended his employment.
According to the EEOC's suit, David Gaiser II was hired by Remedy and assigned to work as a general laborer at Lornamead's Tonawanda, N.Y., facility in June 2013. During his employment, Gaiser was diagnosed with autosomal dominant polycystic kidney disease, a chronic condition characterized by the growth of multiple cysts in the kidneys. In June 2016, Gaiser was assigned to run a machine that required continual bending and twisting, which aggravated his kidney condition and caused him severe pain. Gaiser suggested several accommodations that could enable him to perform his job duties. Instead, Lornamead directed Remedy to end Gaiser's three-year assignment at Lornamead. Remedy failed to place Gaiser at another job with a different client.
Such alleged conduct violates the Americans with Disabilities Act (ADA), which prohibits discrimination based on disability and requires employers to provide a reasonable accommodation to individuals with disabilities. The EEOC filed suit (EEOC v. Lornamead, Inc. and Remedy Intelligent Staffing, Inc., Civil Action No. 1:18-cv- 00841) in U.S. District Court for the Western District of New York, Buffalo Division, after first attempting a pre-litigation settlement through the EEOC's conciliation process.
In addition to the $50,000 in monetary relief, the three-year consent decree settling the suit requires Lornamead to adopt new policies and procedures on disability discrimination and on providing accommodations to employees with disabilities. The decree also requires the company to train all supervisors, managers, and human resources personnel at the Tonawanda facility on Lornamead's obligations under the ADA. The company will also provide training to non-supervisory employees, including temporary employees placed by Remedy, on their rights under the ADA. Remedy will distribute its new policies explaining the ADA's prohibition against disability discrimination and Remedy's duty to provide reasonable accommodations to all employees and newly hired employees. Remedy will also provide training to all supervisors, managers, and human resources personnel responsible for temporary employees assigned to Lornamead's Tonawanda facility. The decree further subjects both employers to reporting, monitoring and record-keeping requirements.
"As joint employers, Remedy and Lornamead share a legal duty to provide reasonable accommodations to people with disabilities," said Jeffrey Burstein, regional attorney for the EEOC's New York District Office. "We appreciate both employers' willingness to resolve this case without protracted litigation."
Kevin Berry, district director of the New York District Office, said, "The purpose of the ADA is to ensure equal employment opportunities to qualified people with disabilities. Firing a person because he or she needs an accommodation due to a disability is against the law, and the EEOC will continue to hold employers accountable."
Elizabeth Fox-Solomon was the EEOC's lead trial attorney for this case.
The EEOC's New York District Office is responsible for processing discrimination charges, administrative enforcement, and the conduct of agency litigation in Connecticut, Maine, Massachusetts, New Hampshire, New York, northern New Jersey, Rhode Island, and Vermont. The Buffalo Local Office conducted the investigation resulting in this lawsuit.
PKD Foundation
From healio.com
Researchers of polycystic kidney disease honored with Kaplan International Prize for Advancement
York Pei, MSc, MD, FRCPC, and Bradley Yoder, PhD, were presented with the Lillian Jean Kaplan International Prize for Advancement at the World Congress of Nephrology in Melbourne, Australia, according to a press release from the PKD Foundation.
The Lillian Jean Kaplan International Prize recognizes individuals whose scientific work results in improving the knowledge and treatment of polycystic kidney disease.
“It is my distinct honor to present both Pei and Yoder with the Lillian Jean Kaplan International Prize for their most significant research in the polycystic kidney field. And, we deeply appreciate Mr. Kaplan’s generous commitment in recognizing researchers in their quest to advance treatments for PKD,” Andy Betts, CEO of the PKD Foundation, said in the release. “The pioneering studies of these researchers provide great hope for the future for all PKD patients.”
According to the release, both researchers were awarded $50,000, a sculpture, a citation depicting their work and an opportunity to lecture during the World Congress of Nephrology about their research. Pei, a professor of medicine at the University of Toronto, focused on genetic, genomic, clinical and translational research and has made a significant contribution to advance diagnosis, prognosis and development of novel treatment in autosomal dominant polycystic kidney disease.
As professor and chair of the department of cell, developmental, and integrative biology at the University of Alabama at Birmingham Medical School, Yoder has spent 2 decades focused on understanding the function of the primary cilium in multiple tissues and during development, with a long-standing interest in how loss of cilia function contributes to cyst development in the kidney. His recent research has uncovered roles for primary cilia in regulating innate immune responses following renal injury that accelerates cyst progression.
BUFFALO, N.Y. - Remedy Intelligent Staffing, LLC, a California-based staffing firm, and Lornamead, Inc., a manufacturer headquartered in New York City, will pay $50,000 and furnish other relief to settle a disability discrimination lawsuit filed by the U.S. Equal Employment Opportunity Commission (EEOC), the federal agency announced today. The EEOC charged that Remedy and Lornamead violated federal law when they refused to provide a reasonable accommodation to a long-term temporary employee that would have enabled him to continue to work after his kidney condition worsened, and instead ended his employment.
According to the EEOC's suit, David Gaiser II was hired by Remedy and assigned to work as a general laborer at Lornamead's Tonawanda, N.Y., facility in June 2013. During his employment, Gaiser was diagnosed with autosomal dominant polycystic kidney disease, a chronic condition characterized by the growth of multiple cysts in the kidneys. In June 2016, Gaiser was assigned to run a machine that required continual bending and twisting, which aggravated his kidney condition and caused him severe pain. Gaiser suggested several accommodations that could enable him to perform his job duties. Instead, Lornamead directed Remedy to end Gaiser's three-year assignment at Lornamead. Remedy failed to place Gaiser at another job with a different client.
Such alleged conduct violates the Americans with Disabilities Act (ADA), which prohibits discrimination based on disability and requires employers to provide a reasonable accommodation to individuals with disabilities. The EEOC filed suit (EEOC v. Lornamead, Inc. and Remedy Intelligent Staffing, Inc., Civil Action No. 1:18-cv- 00841) in U.S. District Court for the Western District of New York, Buffalo Division, after first attempting a pre-litigation settlement through the EEOC's conciliation process.
In addition to the $50,000 in monetary relief, the three-year consent decree settling the suit requires Lornamead to adopt new policies and procedures on disability discrimination and on providing accommodations to employees with disabilities. The decree also requires the company to train all supervisors, managers, and human resources personnel at the Tonawanda facility on Lornamead's obligations under the ADA. The company will also provide training to non-supervisory employees, including temporary employees placed by Remedy, on their rights under the ADA. Remedy will distribute its new policies explaining the ADA's prohibition against disability discrimination and Remedy's duty to provide reasonable accommodations to all employees and newly hired employees. Remedy will also provide training to all supervisors, managers, and human resources personnel responsible for temporary employees assigned to Lornamead's Tonawanda facility. The decree further subjects both employers to reporting, monitoring and record-keeping requirements.
"As joint employers, Remedy and Lornamead share a legal duty to provide reasonable accommodations to people with disabilities," said Jeffrey Burstein, regional attorney for the EEOC's New York District Office. "We appreciate both employers' willingness to resolve this case without protracted litigation."
Kevin Berry, district director of the New York District Office, said, "The purpose of the ADA is to ensure equal employment opportunities to qualified people with disabilities. Firing a person because he or she needs an accommodation due to a disability is against the law, and the EEOC will continue to hold employers accountable."
Elizabeth Fox-Solomon was the EEOC's lead trial attorney for this case.
The EEOC's New York District Office is responsible for processing discrimination charges, administrative enforcement, and the conduct of agency litigation in Connecticut, Maine, Massachusetts, New Hampshire, New York, northern New Jersey, Rhode Island, and Vermont. The Buffalo Local Office conducted the investigation resulting in this lawsuit.
PKD Foundation
From healio.com
Researchers of polycystic kidney disease honored with Kaplan International Prize for Advancement
York Pei, MSc, MD, FRCPC, and Bradley Yoder, PhD, were presented with the Lillian Jean Kaplan International Prize for Advancement at the World Congress of Nephrology in Melbourne, Australia, according to a press release from the PKD Foundation.
The Lillian Jean Kaplan International Prize recognizes individuals whose scientific work results in improving the knowledge and treatment of polycystic kidney disease.
“It is my distinct honor to present both Pei and Yoder with the Lillian Jean Kaplan International Prize for their most significant research in the polycystic kidney field. And, we deeply appreciate Mr. Kaplan’s generous commitment in recognizing researchers in their quest to advance treatments for PKD,” Andy Betts, CEO of the PKD Foundation, said in the release. “The pioneering studies of these researchers provide great hope for the future for all PKD patients.”
According to the release, both researchers were awarded $50,000, a sculpture, a citation depicting their work and an opportunity to lecture during the World Congress of Nephrology about their research. Pei, a professor of medicine at the University of Toronto, focused on genetic, genomic, clinical and translational research and has made a significant contribution to advance diagnosis, prognosis and development of novel treatment in autosomal dominant polycystic kidney disease.
As professor and chair of the department of cell, developmental, and integrative biology at the University of Alabama at Birmingham Medical School, Yoder has spent 2 decades focused on understanding the function of the primary cilium in multiple tissues and during development, with a long-standing interest in how loss of cilia function contributes to cyst development in the kidney. His recent research has uncovered roles for primary cilia in regulating innate immune responses following renal injury that accelerates cyst progression.
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