Clinical Validation Study for KidneyIntelX™ Announced

In a recent press release, RenalytixAI announced the initiation of its clinical validation study for KidneyIntelX™. RenalytixAI develops artificial intelligence-enabled diagnostics for kidney disease. KidneyIntelX is designed to diagnose and improve clinical management of patients with type 2 diabetes and those of African ancestry with fast-progressing kidney disease.

The expanded validation study program includes investigators from Johns Hopkins Medicine, Emory University, the Icahn School of Medicine at Mount Sinai, Northwestern University, Harvard University, and Brigham and Women’s Hospital. KidneyIntelX will use matching learning algorithms to assess the combination of predictive blood-based biomarkers, including sTNFR1, sTNFR2, and KIM1, in combination with data from electronic health records (EHRs).

Michael J. Donavan, MD, PhD, professor of pathology at the Icahn School of Medicine at Mount Sinai and chief medical officer at RenalytixAI, said, “The scale and clinical breadth of this validation provides a rare opportunity to evaluate how AI can aid our ability to detect fast-progressing kidney disease. KidneyIntelX will give doctors a powerful tool to identify which individuals with kidney disease are likely to progress to end-stage disease and should be treated more aggressively.”

The clinical validation will assess approximately 5000 patient blood samples and EHRs sourced from a multi-center collaboration including Emory University and Mount Sinai. The expanded patient cohort will increase the statistical power of KidneyIntelX and will provide insight into the design of the planned clinical utility study. Data from the validation study will also be used to support the submission of KidneyIntelX for review by the US Food and Drug Administration in 2019.

Outset Medical Appoints New Executives

Outset Medical has announced the appointment of two new executives: Michael Aragon, MD, chief medical officer, and Stacey Porter, vice president, people operations. Outset Medical is a commercial-stage company delivering the first-of-its kind Tablo® Hemodialysis System into the global market.

Dr. Aragon is a board-certified internist and nephrologist who previously spent 14 years in clinical practice and as a medical director for DaVita and US Renal Care. He is the chairman of the board of directors for the End-Stage Renal Disease Network of Texas.

In a press release from Outset Medical, Dr. Aragon said, “The leadership team at Outset is dedicated to improving care for patients with end-stage kidney disease with a simplified, more cost-effective dialysis solution. Having served hundreds of patients firsthand for more than a decade, I’ve seen the burden of dialysis on patients, their families, and their healthcare providers. I share Outset’s passion for bringing much needed innovation to the industry, and look forward to helping lead the organization as it transforms the dialysis experience.”

Stacey Porter has more than 18 years of leadership development and organizational learning implementation in the technology, pharmaceutical, and medical device industries. She holds a master’s degree in clinical social work and is completing a PhD in industrial/organizational psychology.

Leslie Trigg, Outset CEO, said, “We are thrilled to welcome Michael and Stacey to the Outset Medical team. Both are outstanding leaders and experts in their fields, and will play an instrumental role in helping us deliver on our mission to improve global dialysis care and offer a better experience for providers and patients.

“Michael joins an esteemed group of nephrology experts involved with Outset, including Dr. Glenn Chertow, chief, division of nephrology, Stanford University School of Medicine; Dr. Sarah Prichard, an academic nephrologist and former medical affairs and R&D leader at Baxter; and Dr. Louis Alvarez, chair of nephrology, Palo Alto Medical Foundation, Sutter Health, and Outset’s chief advisor for technology and innovation.”

Plant-Based Diets in Individuals with CKD

Results from a peer-reviewed study examining the potential health benefits of plant-based diets in patients with chronic kidney disease (CKD) were reported online in the Clinical Journal of the American Society of Nephrology. Plant-based diets such as DASH (Dietary Approaches to Stop Hypertension) are high in fiber, low in saturated fat, and contain sources of phosphorus, magnesium, calcium, and have low levels of sodium.

However, plant-based diets also contain sources of potassium, which may be fatal for persons with reduced kidney function if the level of potassium in their blood spikes (hyperkalemia). Individuals with CKD may not be able to maintain a plant-based diet due to the risk of hyperkalemia.

The study, supported by Relypsa, Inc., a Vifor Pharma Group Company, examined the benefits of newly available once daily potassium binders to facilitate the balance of potassium in the body, enabling patients with CKD to maximize the benefits of healthy eating, including the plant-based diet.

In the journal article, Deborah J. Clegg, PhD, lead study investigator, said, “Some individuals whose remaining kidney function is not adequate to avoid elevations or wide variations in serum potassium associated with high-potassium dietary intake may be precluded from consuming diets that are plant based due to the potential adverse event of hyperkalemia. For this subset of individuals, the availability of newer once daily potassium binders may facilitate achievement of potassium homeostasis while maximizing the benefits of diets enriched in potassium. Prospective data are needed to confirm this hypothesis.”

Analysis of Data on Patients with AKI Treated with Outpatient Dialysis

Preliminary results from an analysis of new data on more than 9000 patients with acute kidney injury (AKI) treated at Fresenius Kidney Care outpatient dialysis centers has been released. According to the analysis, 36% of patients with AKI requiring outpatient dialysis recovered kidney function with 90 days of in-center hemodialysis initiation; 16% with persistent AKI at 90 days recovered kidney function by day 150. Overall, 38% of patients with AKI who required outpatient dialysis treatment recovered kidney function within 150 days of therapy initiation.

Frank Maddux, MD, chief medical officer and executive vice president for clinical and scientific affairs at Fresenius Medical Care North America, said in a press release, “These groundbreaking data hold enormous promise for developing further insights into the treatment of acute kidney injury and this is the first time significant data of this type have been available anywhere. This is an exciting step in our ongoing efforts to improve the treatment of people with acute kidney injury and create more personalized care so that patients are more likely to recover kidney function.”

The preliminary analysis also examined other clinical measures, such as the type of vascular access used, rates of ultrafiltration, and biochemical measures in the 90 days after initiation of outpatient dialysis therapy. Other findings include one in five patients who initiate outpatient in-center dialysis are diagnosed with AKI; 44% of those patients progress to end-stage renal disease within 150 days of initiating hemodialysis.

Streamlining the Pediatric Kidney Transplant Process

Cincinnati Children’s Hospital Medical Center is implementing strategies to minimize barriers to kidney transplant. The improvements include shortening the amount of time between receiving a patient referral and conducting the committee review.

David Hooper, MD, medical director of the Kidney Transplant Program, said, “Many patients referred to us for a transplant evaluation are on dialysis, and it is critical to get them to our review committee as quickly as possible.” The team partnered with Clinical Concierge Services, a group within the hospital that specializes in scheduling complex hospital visits. Clinical concierges schedule nearly all tests, procedures, and physician visits; the change reduced the referral-to-review process to ≤90 days.

Other initiatives include a partnership with the National Kidney Registry to offer paired kidney exchanges, resulting in shorter wait times and more opportunities to find an optimal match.