St. Clair Nephrology

Key takeaways: According to the Centers for Disease Control and Prevention (CDC) in 2019, more than 37 million U.S. adults have chronic kidney disease (CKD) and 90 percent are undiagnosed. Early diagnosis of CKD and optimal management by following evidence-based medicine and guidelines may increase the chance of slowing down disease progression and preventing severe outcomes. The PINC AI™ Applied Sciences (PAS) team is utilizing Improvement Science to help impact clinician behavior change and encourage the use of evidence-based guidelines in diagnosing and treating CKD. What is CKD? Chronic kidney disease (CKD) is characterized by progressive irreversible loss of kidney function over time. Early stages can be asymptomatic, disease progression occurs slowly and often in the presence of other comorbidities. Knowing the underlying causes of CKD and receiving a timely diagnosis may delay disease progression and the need for dialysis and kidney transplantation. Because the kidney filters blood, removes waste, and regulates nutrients, complications including gout, anemia, secondary hyperparathyroidism (SHPT), bone disease, heart disease and fluid buildup can develop when kidney function is lost. However, according to the Centers for Disease Control and Prevention (CDC), in 2019 more than 37 million adults in the U.S. have CKD and 90 percent are undiagnosed. During Premier’s 2023 Breakthroughs Conference and Exhibition, Dr. Joel Topf, Medical Director of St. Clair Nephrology Research in Roseville, Michigan, and a nephrologist at Ascension Corewell, and Dr. Mark Loafman, Chair of Family and Community Medicine at Cook County Health, presented information on CKD and the work outlined below to help providers diagnose CKD early, impact patient care and help lower overall costs for hospitals and health systems. How is CKD diagnosed? Typically, patients can obtain a CKD diagnosis through simple blood and urine tests. The blood tests are used to check for creatinine, a waste product produced by muscles, in the blood to see how well the kidneys work. Urine tests check for protein in the urine that indicates kidney damage. What are the Challenges of Diagnosing CKD? A diagnosis of CKD can be made with simple blood or urine tests. However, patients may not have a primary care provider (PCP) and, even if they do, patients aren’t always aware of CKD which can pose difficulties in diagnosing CKD and identifying those patients at high-risk[i]. In addition, PCPs may lack clinical decision support (CDS) tools and be less familiar with the Clinical Practice Guidelines and Clinical Practice Recommendations on CKD resulting in underutilizations of CKD-focused screenings. At Breakthroughs 23, some clinicians mentioned discouragement with a lack of CKD-specific performance measures and/or no multidisciplinary approaches to diabetes, hypertension, and CKD management in place. Therefore, it’s prudent to conduct outreach that engages health systems and providers to support them in helping to identify barriers and taking actions aimed at improving diagnosis and management of CKD patients. Why is early detection important? Early diagnosis of CKD, especially among high-risk groups, can lead to optimal management by following evidence-based medicine and guidelines. Proper management may increase the chance of slowing down disease progression and preventing severe outcomes, even death. Not to mention, the progression of CKD typically results in increased cost and late-stage CKD is associated with substantial economic cost.1 Better management of CKD may help to reduce overall costs associated with CKD and could improve management of co-morbid conditions such as diabetes, hyperlipidemia and hypertension. What are the current tests, treatments and guidelines? When it comes to testing for CKD, clinicians need to be proactively looking for comorbidities, signs and symptoms. Patients may not feel ill or notice any symptoms until CKD is advanced. “Clinicians need to screen patients with comorbidities such as cardiovascular disease, hypertension, hyperlipidemia or type two diabetes. Diabetes guidelines indicate the need to check albumin to creatinine ratio on an annual basis,” said Dr. Topf. The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines define CKD by the presence of kidney damage or decreased glomerular filtration rate (GFR) for three or more months, irrespective of the cause. Albuminuria can be used as a marker for kidney damage (increased glomerular permeability, urine albumin-to-creatinine ratio [UACR] > 30mg/g) and estimated GFR (eGFR) < 60 mL/min/1.73m2 is considered decreased GFR. “This testing is inexpensive and non-invasive. In addition to a urinalysis with the albumin-creatinine ratio, clinicians should also get the eGFR,” said Dr. Topf. The KDIGO has a CKD guideline, but it hasn’t been updated since 2012. Revisions are currently underway, and clinicians can refer to the draft until it becomes final. However, during the presentation at Premier’s 2023 Breakthroughs Conference and Exhibition, some clinicians felt evidence should be generated that supports proven treatment and outcomes and then the guidelines should be adapted around those findings. “When patients get the CKD diagnosis, they get on a track and they’re more likely to get therapy and that makes a big difference,” said Dr. Topf. How are PINC AI™ Applied Sciences (PAS) and AstraZeneca (AZ) partnering for change? Rising disease and economic burden of CKD led PAS and AZ to partner to uncover undiagnosed CKD. Together, the team is hoping to impact clinician behavior change and help speed the uptake of evidence-based guidance. In addition, they are working to identify opportunities in optimizing CKD screening, diagnosis and treatment within the healthcare setting and developing tailored solutions for patients with undiagnosed CKD. The team is working to develop a comprehensive provider and patient outreach plan, related tools and materials to help raise awareness about CKD early diagnosis and treatment among providers and patients. “It’s important to have patient empowerment. There's got to be patient education or as I've learned to say, engagement,” said Dr. Loafman. “Because knowledge is one thing, but if you don't act on the knowledge, it's useless.” When we get patients engaged in their own care there is empowerment. In addition to outreach plans and education materials, the team is actively building a CKD framework based on PAS’s Improvement Science framework methodology to help organize a clinical approach to improving CKD diagnosis and care. The framework includes education resources and an on-demand webinar for clinicians that the PAS team and AZ developed together, including a Care Journey Roadmap, CKD CDS alerts and National and Facility Reports. Is there an equitable approach for GFR estimation? Common formulas used to measure the kidney’s filtering function included race as a variable. Researchers have raised concerns that these race-based equations may result in misclassification and contribute to unjust disparities in CKD treatment and outcomes. The National Kidney Foundation (NKF) and the American Society of Nephrology reassessed inclusion of race in the estimation of GFR in the U.S., its implications for diagnosis and management of patients with, or at risk for, kidney diseases. They recommend: Implementation of the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation. Facilitation of increased, routine, and timely use of cystatin C, especially to confirm estimated GFR in adults at risk for or have CKD. Continuation of research on GFR estimation with new endogenous filtration markers and on interventions to eliminate race and unjust disparities. Utilizing a race-free eGFR equation, allows researchers to equitably calculate eGFR that is accurate, unbiased, and a precise GFR measurement and estimation without the inclusion of race to help promote equity and reduce disparate care. How can patients and providers get educated on CKD? The team plans to develop a comprehensive clinician and patient outreach plan and related education tools and materials to help raise awareness about CKD, early diagnosis and treatment among clinicians and patients. The Outreach Plan will include the following materials: Letter to hospital administrators and other key stakeholders that describes the burden of CKD and issues with diagnosing CKD. The letter will outline the potential social and economic consequences of possible inaction. Educational webinars that will provide information on timely diagnosis, treatment and care management for patients with CKD. National and Facility Reports that are based on data generated from the study. National Reports will provide a national view of the burden of CKD and gaps in CKD diagnosis. Facility reports will give each facility an opportunity to see how well they are doing with CKD diagnosis and identify opportunities to improve. Introduction of CKD CDS Alert that details the purpose and contents of the CDS alert as well as how to access the CDS alert to raise awareness about the tool. Populated Framework that will help improve patient care at the system level and point of care. The proprietary populated framework will be focused on identifying core strategies or areas of opportunities, which will include local level processes and challenge-based recommendations for addressing CKD care management and treatment. Care Journey Roadmap will map the workflow for CKD patient care management and treatment within a health system. Clinician and Patient Educational Resources will be created to empower patients and clinicians in improving care, management and treatment of CKD. Can a CDS alert help? In diagnosing CKD, identifying the right patients is the natural first step. But how can clinicians get assistance with diagnosing this difficult condition? PAS and PINC AI™ Stanson are working to develop CDS alerts to help flag patients who could potentially have undiagnosed CKD or patients diagnosed with CKD that may require modification to their current treatment plan. How will these resources help close gaps in care? PAS’s collaboration with AZ will help build the CKD populated framework that can help hospitals and health systems get processes and challenge-based recommendations in place to help assess, diagnose and optimize care management and treatment for the right patients at the right time. The framework helps clinicians tie it all together and understand their ability to adopt potential new approaches. It provides an overview of the CKD patient journey as well as strategies and tools to support detection, treatment and management. What lies ahead? PAS and AZ will continue to advance research and utilize improvement science and technology-enabled tools to help hospitals and health systems better prepare and improve processes for managing and treating patient populations who experience CKD. The CDS alert, outreach plan and framework will all serve at the system level to match tools, resources and structures as needed, and it relies on clinicians for confirmation and refinement of processes. The benefits of this multi-disciplinary approach include: Earlier identification of patients with CKD. Coordinated patient access to clinicians working together as a care team. Robust tracking of results and outcomes for continuous quality improvement. Improved patient assessment, diagnosis and care is critical to treating CKD and giving these patients a better quality of life. PAS and our partners are committed to this work and continue to advance research and develop technology-enabled tools to help hospitals and health systems better prepare and improve their processes for treating this vulnerable patient population. For more on this topic: Register for an educational webinar on Sept. 21 at 2:00 p.m. EST for more details on early diagnosis, treatment and care management for patients with CKD. Read more about PINC AI™ Applied Sciences and explore our research and analytics solutions. AUTHORS: Rena Moon, MD, MPH Principal Research Scientist, PINC AI™ Applied Sciences, Premier Dr. Moon has more than 11 years of experience in academic surgical research, epidemiology, and health economics and outcomes research. She has presented and authored many abstracts, posters, and peer-reviewed manuscripts at national and international conferences and journals. Ning Rosenthal, MD, MPH, PhD Senior Principal of Applied Research, PINC AI™ Applied Sciences, Premier Dr. Rosenthal is lead of the Applied Research team at PINC AI™ Applied Sciences. She has over 20 years of research experience in epidemiology and health economics and outcomes research (HEOR). Many of her studies have been presented at national and international scientific conferences and published in top peer-reviewed journals. Jeff Vawter, MHA Senior Director, Improvement Science, PINC AI™ Applied Sciences, Premier Jeff strategically leads the deployment of improvement science projects for PINC AI™ Applied Sciences, supporting hospitals, health systems and life sciences organizations as they implement clinical surveillance, provider education, user experience assessments and create white papers or manuscripts for potential peer-reviewed publication. References: Freeman C et al. F1000Research 2019, 8:1242. [i] Primary Care Detection of Chronic Kidney Disease in Adults with Type-2 Diabetes: The ADD-CKD Study (Awareness, Detection and Drug Therapy in Type 2 Diabetes and Chronic Kidney Disease) - PMC (nih.gov)

STAMFORD, Conn., Jan. 17, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the Company will host an in-person and virtual Capital Markets Day in New York City on Thursday, February 16, 2023, from 10:00 a.m. to 1:00 p.m. EST. The event will highlight the launch of KORSUVA® (difelikefalin) injection and feature presentations during which healthcare providers will discuss the unmet medical need in pruritus associated with non-dialysis dependent chronic kidney disease, atopic dermatitis and notalgia paresthetica. The Company’s registrational Phase 2/3 program of oral difelikefalin in notalgia paresthetica patients with moderate-to-severe pruritus will also be discussed. Presenters will include: Christopher Posner, President and Chief Executive Officer, Cara TherapeuticsJoana Goncalves, M.D., Chief Medical Officer, Cara TherapeuticsEric Vandal, Senior Vice President, Commercial, Cara TherapeuticsJoel Topf, M.D., FACP, Assistant Clinical Professor of Medicine at Oakland University William Beaumont School of Medicine, and Medical Director of St. Clair Nephrology ResearchJennifer Scherer, M.D., Assistant Professor of Palliative Care and Nephrology at the NYU Grossman School of Medicine, and Director of the Kidney CARES Program at NYU Langone HealthRaj Chovatiya, M.D., Ph.D., Assistant Professor of Dermatology at the Northwestern University Feinberg School of Medicine, and Director of the Center for Eczema and Itch at Northwestern UniversityShawn Kwatra, M.D., FAAD, Assistant Professor of Dermatology at the Johns Hopkins University School of Medicine, and Director of the Johns Hopkins Itch Center To register for the event, please click here. A live webcast of the event will be accessible under “Events & Presentations” in the News & Investors section of the Company’s website at www.CaraTherapeutics.com. A replay of the webcast will be archived on the Company’s website following the event. About Cara Therapeutics Cara Therapeutics is a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company’s novel KORSUVA® (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The Company is developing an oral formulation of difelikefalin and has initiated Phase 3 programs for the treatment of pruritus in patients with non-dialysis dependent advanced chronic kidney disease and atopic dermatitis. The Company has completed a Phase 2 proof-of-concept trial of oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica and plans to initiate a Phase 2/3 clinical trial program in the first quarter of 2023. For more information, visit www.CaraTherapeutics.com and follow the company on Twitter, LinkedIn and Instagram. MEDIA CONTACT:Annie Spinetta6 Degrees973-768-2170aspinetta@6degreespr.com INVESTOR CONTACT:Iris Francesconi, Ph.D.Cara Therapeutics203-406-3700investor@caratherapeutics.com