The response to the COVID-19 pandemic by the Department of Medicine’s large Division of Nephrology was multifactorial, as Joji Tokita, MD, Associate Professor of Medicine (Nephrology) at the Icahn School of Medicine at Mount Sinai, explains.

“It was a multifaceted task that was extraordinarily complex,” he says. “But as far as our work during the pandemic is concerned, I think it was a great success.”

Part of the response to the challenge of the pandemic included regular consultations with other local academic health systems, major national dialysis providers, supply chain management, the New York ESRD [end-stage renal disease] network, and the New York State Department of Health. Home dialysis programs ramped up, and novel solutions were developed to allow patients to continue home therapy while still receiving all necessary monitoring and care. At the height of the pandemic, urgent-start peritoneal dialysis was extended to support inpatients with acute kidney injury requiring dialysis. Telemedicine played a key role in allowing nephrologists to keep track of their patients’ health remotely.

A Challenge and an Opportunity

The Division of Nephrology of the Mount Sinai Health System has nearly 100 nephrologists on staff and more than 25 clinical fellows. Central to the Division’s mission is its belief in health equity and access to care. As such, the Division has developed clinics in outer New York City boroughs and staffed nephrologists at more than 10 dialysis facilities across the city. Faculty members see patients in diverse locations throughout Manhattan and in Queens; Brooklyn; and Oceanside, Long Island.

During the pandemic, the size of the Health System was both a challenge and an opportunity, Dr. Tokita explains. “Large programs can generate a nexus of opportunity for thought and innovation. However, they can be complex to manage, and integration and standardization across geographies often takes time.”

Ensuring continuation of clinical operations throughout the Health System was indeed challenging. “For example, most dialysis patients receive treatment at a nearby center three times per week and many have complex medical conditions,” Dr. Tokita says. “The need to travel to and from the center as well as share close quarters during several hours of treatment required us to think about how best to mitigate these increased risks.” Health care workers were also affected by the pandemic, presenting additional challenges in ensuring centers remained open.

“A major concern was that if those patients were unable to receive maintenance hemodialysis in their home facility, they would potentially flood hospital emergency rooms, which would threaten to collapse the health care system,” Dr. Tokita says. The Division needed to develop very clear plans right from the start to ensure that would not happen.

“Throughout the pandemic it was imperative that we ensure continuity of operations across all of our dialysis facilities,” Dr. Tokita says. That the Division was able to do just that proved to be a notable success of Mount Sinai’s pandemic health care.

Stratifying Risk for Chronic Kidney Disease

Chronic kidney disease (CKD) is a significant and growing public health problem. The Centers for Disease Control and Prevention notes that approximately 15 percent of U.S. adults, or 37 million people, are thought to have CKD. Diabetes and high blood pressure are leading causes of CKD, as are heart disease, obesity, and genetic predisposition. Significantly, of the patients with CKD, as many as 90 percent do not know they have it, and of those with severe CKD, almost 40 percent are unaware of the condition. About a quarter of adults with type 2 diabetes develop diabetic kidney disease, and every year about 50,000 patients progress to kidney failure, requiring dialysis or a kidney transplant.

For these reasons, accurate risk stratification of susceptibility to progressive kidney disease is a key clinical objective. Risk stratification historically has used the Kidney Disease Improving Global Options (KDIGO) approach, in which progression is defined as a sustained drop in glomerular filtration rate (GFR) category and/or a 25 percent decrease from GFR baseline, while rapid progression is a decline in GFR of >5 ml/min/1.73m2 per year.

A novel bioprognostic test, KidneyIntelX, developed by Mount Sinai faculty and licensed to Renalytix AI, is a lab test that defines the risk of CKD progression in patients with type 2 diabetes and CKD stages 1-3. The test combines estimated GFR (eGFR), novel serum biomarkers (sTNFR1, sTNFR2, KIM-1), urine albumin-creatinine ratio (uACR), and electronic health record data to provide a low, intermediate, or high-risk score of kidney function decline in the next five years. It addresses issues including intra-individual variability of eGFR, uACR, and hyper-filtration that masks early diabetic kidney disease. It provides risk stratification, to appropriately triage care and minimize patient burden and resource use.

Mount Sinai is studying the impact of KidneyIntelX testing on clinical decision-making at its ambulatory practices in an IRB-approved Real World Evidence study. Interim results were published in 2022 in Journal of Primary Care & Community Health. These interim results from 1,686 patients with six months of data found:

1. 1.

   Type 2 diabetes care: a 10 percent improvement in hemoglobin A1c

2. 2.

   CKD care: a 15 percent improvement in albuminuria in low-intermediate risk groups

3. 3.

   Early-stage diabetic kidney disease: Patients with high-risk scores received more frequent clinical visits, guide-recommended care, and specialist referrals

4. 4.

   Fifty-three percent of high-risk patients followed up within one month of their test and 57 percent had some action taken (medication change or referral) within three months, compared with 13 percent and 35 percent, respectively, in low-risk individuals

5. 5.

   Twenty-five percent of high-risk patients started SGLT2 inhibitors, medications that reduce progression of CKD, compared with 7 percent in the low-risk group.

Gaps remain in the continuum of care for patients with diabetic CKD. Based on these findings, KidneyIntelX testing should help. Dr. Tokita, the first author of the study, notes, “A key aspect of this work is improving patient and provider awareness of the condition and early use of evidence-based therapies currently available to treat it and reduce progression.”

KidneyIntelX is a commercially available, CLIA-approved predictive test that combines patient information and biomarker results. KidneyIntelX is based on innovative technology developed by Mount Sinai faculty and licensed to Renalytix AI. Mount Sinai faculty and Mount Sinai have equity ownership in Renalytix AI.