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A preliminary analysis of new data from more than 9,000 patients with acute kidney injury receiving outpatient dialysis provides important insights, including that a significant number have long term recovery of kidney function. Dr. Frank Maddux, Chief Medical Officer for Fresenius Medical Care North America, discusses the findings and the effort to create new models of care for these patients.
The preliminary data analysis was first presented to registered nephrologists, clinicians and renal researchers on January 23, 2019 in San Diego, Calif. at Medical Office Live, a series of interactive webinars on the latest clinical and scientific advances in renal care.
Q: Fresenius Medical Care North America (FMCNA) just announced its first preliminary analysis of data from patients with acute kidney injury (AKI) treated in our outpatient dialysis centers. Why is this new data significant?
FM: It’s very significant to have national data on individuals with AKI treated in outpatient dialysis facilities. Data on this scale hasn’t been publicly available anywhere in the world before, so it’s truly groundbreaking and novel information. I believe this data holds enormous promise for developing important insights into the treatment and recovery of acute kidney injury. We hope to use these insights to improve the treatment of people with AKI and create more personalized care that enhances the likelihood of recovery of kidney function.
Q: What exactly is acute kidney injury and how does it compare to end stage renal disease?
FM: Acute kidney injury is an abrupt change in kidney function and causes the kidneys to stop functioning properly. AKI has multiple causes including acute illness, certain medications, injury, or a lack of proper blood flow to the kidney. AKI can occur in people with normal kidney function or in people with chronic kidney disease. Severe AKI can require renal replacement therapy, known as dialysis, to stay alive while the kidney tissue is trying to heal.
Q: What do you believe are the most interesting findings from this preliminary analysis?
FM: I think it’s the fact that distant recovery of kidney function is still possible, and we need to better recognize that it can happen and how to best identify those patients with the possibility of recovering kidney function. Our analysis showed that about one-third of AKI patients who begin
outpatient dialysis will recover kidney function in the first 90 days of starting their outpatient treatment. About 1 in 6 patients with persistent acute kidney injury after 90 days will actually regain kidney function by day 150. That’s something that is important to understand and has implications for care. These are the types of findings that will spur us to look deeper into the data to answer many additional questions that come up as to why and how. It is very exciting to see how the kidneys recover from injury so many months later.
Q: Why does FMCNA have this new data? What changed?
FM: Historically, patients with acute kidney injury who required dialysis (AKI-D) were treated in hospitals, at least if they were Medicare patients. As of January 1, 2017, the Centers for Medicare and Medicaid Services (CMS) has allowed these patients to receive dialysis at outpatient dialysis centers, which had primarily focused on treating patients with end-stage renal disease (ESRD).
When that rule changed, we began capturing the data from patients with AKI being admitted to our Fresenius Kidney Care centers, just as we do with all of our other patients. We have been undertaking descriptive analytics to further understand the clinical course of AKI in the outpatient dialysis setting. We wanted to understand what patients with AKI look like and how they compare to our other patient populations. We also wanted to better understand resolution of acute kidney injury.
Q: How will this new information help you treat these patients with AKI going forward?
FM: It’s very exciting because we’ve never been able to look at this on a population basis with a large national sample of patients with AKI. There have been smaller studies at single centers or locales, but nothing of the magnitude we have presented recently. So we now have the opportunity to untangle what we should be doing clinically for the management of acute kidney injury to try and help these patients achieve the best opportunity to recover kidney function. We need to develop a model of care for patients with AKI that may look different than for those patients who need dialysis as result of slow progression of chronic kidney disease and ESRD. We have this new group of patients we can better support and treat by understanding their circumstances.
Many physicians would have the baseline belief that if after 90 days the acute kidney injury hasn’t recovered, it will not. Our data highlights the potential for renal recovery after 90 days. It’s important to not give up on people’s possibility of recovering at a late stage. If we can better understand the factors associated with late recovery that would be extremely helpful. I think we have a real opportunity to advance this science as we continue this work to evaluate and understand these patients. Knowing more about the causes of AKI and the natural history of recovery will help to personalize an approach for those suffering from such a severe systemic disorder.
Dr. Frank Maddux is Chief Medical Officer and Executive Vice President for Clinical and Scientific Affairs at Fresenius Medical Care North America. Prior to joining FMCNA in 2009, Maddux developed one of the first laboratory electronic data interchange programs for the U.S. dialysis industry. He later created one of the first web-based electronic health record solutions, now marketed under Acumen Physician Solutions and was a practicing nephrologist for nearly two decades. An alumnus of Vanderbilt University, he earned his doctor of medicine from the School of Medicine at the University of North Carolina at Chapel Hill, where he holds a faculty appointment as clinical associate professor.