An estimated 37 million people, about 1 in 7 U.S. adults, have some form of chronic kidney disease (CKD) and 90 percent do not know they have it because the disease is asymptomatic in its early stages. By the time patients do receive a diagnosis, they are often in the advanced stages. High blood pressure and diabetes are major risk factors for CKD and the rising prevalence of these conditions, as well as low public awareness of the disease and barriers to easy testing, contribute to the increasing number of people at risk.
The Chronic Renal Insufficiency Cohort (CRIC) is an ongoing, national multicenter prospective study of patients with CKD sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH). Researchers at Kaiser Permanente, Johns Hopkins, Cleveland Clinic, University of Pennsylvania, and other institutions are examining a broad range of risk factors on the progression of kidney disease and other health consequences. They also are developing and implementing novel approaches to predict the biochemical characteristics of kidney disease using cutting-edge technology.
In the current phase of the study, researchers are examining the feasibility and accuracy of home-based protein and albumin testing in people with CKD. Scanwell Health was chosen as a partner because its smartphone-based test technology and the patient acceptance data from its other at-home tests align with what researchers are hoping to accomplish in this phase. Using Scanwell’s CKD test, patient volunteers collect a urine sample in a foldable, disposable cup and dip a test strip into the sample. After the strip changes color, Scanwell’s mobile app captures a picture of the test strip and computer vision algorithms ensure the picture passes several quality checks before interpreting the image. The semi-quantitative results are displayed to the participant and sent to the study researchers.
While a quantitative result is the gold standard in kidney care, a semi-quantitative value is a good screening tool for the identification and progression of kidney disease. “Patients with kidney disease are often not screened for protein or albumin yet these levels are probably the strongest predictor of the need for future renal replacement therapy,” said Alan S. Go, MD, Principal Investigator for CRIC at Kaiser Permanente. “There is [also] some data suggesting that if patients continue to have worsening levels of protein or albumin or their levels go from low to high, they seem to do much worse in terms of needing kidney replacement therapy down the road.”
Screening patients annually, then, may not be frequent enough. Those who have no protein or albumin in their urine at their annual screening but develop it in the interim, or whose disease is progressing, are getting missed. But there are challenges to accessing healthcare such as location and cost, particularly when public awareness is low, and most early-stage patients are asymptomatic. An at-home test like Scanwell’s can make monitoring kidney health more accessible because patients are able to test themselves at a much lower cost. “We are proving that people with chronic kidney disease, many of whom are older and frail, have the ability to [test] on a monthly basis,” said Dr. Go. “It’s not just the results we’re getting but [the fact that] people are able to do [the test] with the right support.”
Through their partnership in the CRIC study, Kaiser Permanente has helped Scanwell improve and refine the accuracy of its test, while Scanwell has incorporated questions into its mobile app that are helping researchers determine if the semi-quantitative value delivered by the test was influenced by other factors. In addition, Kaiser Permanente is measuring whole blood creatinine for another company in tandem with Scanwell’s test. “The ability to marry those two tests together, along with the questions in Scanwell’s mobile app, allows us to do a more systematic assessment at home on a regular basis…that we would not be able to do readily without a lot man or womanpower,” said Dr. Go.
Researchers are in the process of completing enrollment of approximately 1,250 patient volunteers to use Scanwell’s test monthly for 12 months, and nearly 850 have enrolled so far. Dr. Go and his team will use the data to evaluate the trajectories of volunteers’ protein and albumin levels and determine if doing so allows for earlier identification of people whose disease is progressing. The data also will be used to determine if information from the monthly measurement, whether it’s variability in the test or a pattern in the test results, can help researchers predict who is at higher or lower risk for disease progression. “This [study] is an important first step toward making [this technology] more available to detect disease and monitor kidney health,” said Dr. Go. “We’ve created a platform through the CRIC study and Scanwell Health to, in the future, move toward getting even more accurate and quantitative measures of protein excretion.”
The study results, along with data from the other institutions participating in CRIC study, will be published in a peer-reviewed journal article. In addition, the National Institutes of Health in late 2020 awarded Scanwell a $1.6 million Small Business Innovation Research grant to continue developing and validating its test. The grant will also help the company conduct clinical trials before submitting the test to the U.S. Food and Drug Administration for review.
Click here to learn more about Scanwell’s Chronic Kidney Disease test.