Experts in diabetic nephropathy present a study of the use of the KidneyIntelX test in patients with DKD.
Aida Vega, MD: Let's talk about the study that we're discussing today. Previous literature has shown that a majority of patients with chronic kidney disease, especially those in early stages, may be unaware that they have this condition and they do not display any obvious signs or symptoms. And we know that because we see patients and most of the time, most of them are fine. It'sa bit like hypertension – in general, there are no symptoms. Primary care providers are in the front line, in this patient care area. It's in our hands to prevent the early kidney disease and risk stratification. We need clearly more precise identification of patients with early-stage disease and patients who will experience kidney function decline or progression. Early detection of these patients can lead to better disease management aswe will discuss further in this study. It really impacted how we practice in these centers where this study was done. It was an amazing change in terms of the engagement of the primary care physician in this patient population. And tell me about the KidneyIntelX, what you read in this article, and what the test is.
Fernando Carnavali, MD: This is a bioprognostic blood test. And as we mentioned before, it combines electronic health record information. It will combine that with blood-based biomarkers. And with the machine learning in the background, the provider, us as primary care providers, will have then a prediction of what will happen to the patient that we have in front of us. And again, we're concentrating on the early stages. Now we’re looking at the early stages. So, the objective of the study was looking at these patients with chronic kidney disease in the early stages beside our diabetic patients. And what we know is this was a prospective data collection that was done between March of 2020 and November of 2022.
Aida Vega, MD: There was prospective data collection study to assess and evaluate the impact of KidneyIntelX result on the medical decision-making of health outcomes of patients with early-stage diabetic kidney disease. In the Mount Sinai Health System there were about 75 providers that were engaged in this study with 10 primary care centers and specialty centers.
Fernando Carnavali, MD: Correct.
Aida Vega, MD: The data analyzed the patient's baseline data, 6-month posttest, and a 6-month pre-baseline test, which served as an internal patient control. The metrics that were studied were age, height, gender, race, weight, blood pressure, the EGFR, the urine albumin-creatinine ratio, hemoglobin A1c levels, and glucose levels. The beauty of this was that the medical history that was in the electronic health record was integrated into this and they could extract the data of the clinical treatments and care teams decisions based on the results of the test. The patients enrolled were patients with type 2 diabetes and diabetic kidney disease stages I through III that were identified by the study coordinators in the EMR. The clinical variables and assay results that were investigated were the soluble tumor necrosis factor 1 and 2, and the kidney injury molecule-1 as well. And as we said, the patients were identified between November of 2020 and March of 2022. And these patients that were included in the study or were eligible for this study were adult patients with type 2 diabetes, in stage I to III, as well as an EGFR between 30 to 50 or if they had an EGFR of greater than 60 with evidence of albuminuria as identified by urine albumin-creatinine ratio of greater than 30 mg per gram. After the lab variables were done, the KidneyIntelX risk score was calculated, and the providers would get a result – high risk, intermediate risk, or low risk. The providers would use that score to be able to guide them as to how they're going to manage the patient's care. And the demonstration of risk-based clinical impact within 2, 3 to 6 months of baseline KidneyIntelX test done was that the clinical impact was defined as using the following measures: a 20% increase in referrals to specialty services, a 20% increase in the use of statins, or a dose adjustment of the ACE or ARB or a 20% increase in the patients treated with SLGT2 inhibitors or GLP-1s or glucagon-like peptide receptor agonists. And as you know, these are guidelines by the American Diabetes Association that many clinicians are yet instituting into their practice for patients who have diabetic kidney disease or heart disease or heart failure. So, putting that 20% increase in patients to have these novel drugs utilized was an important impact in this study.
Fernando Carnavali, MD: And if I may add to that, what we know regarding referrals, that many of the people when they started dialysis perhaps, they have not seen anybody the year before, they haven't seen the nephrologist, perhaps they have not been in contact with the primary care doctors. We also know about the optimizations of the ARBs and ACE is now there. So, this 20% is a significant increase.
Aida Vega, MD: Yes. And despite the fact that the ACE and ARB guidelines have been around for a long time for diabetics and diabetics who have kidney disease, it's impressive that many providers either do not maximize their…the dose of the ACE inhibitors or don't start them, the ACE ARBs on these patients where it's indicated.
Fernando Carnavali, MD: And again, the point that you brought about the SGLT2 inhibitors is fundamental because what we get from the optimization of ARBs is now what we've seen with SGLT2, correct? And I heard somebody say that SGLT2 perhaps should be in the water by now.
Aida Vega, MD: Yes.
Fernando Carnavali, MD: So, I agree with you that in this particular case the guidelines are dictating something that is not happening. So, seeing this 20% increase in this data is dramatic.
Transcript edited for clarity