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PromarkerD Predicts Renal Function Decline in Type 2 Diabetes in the Canagliflozin Cardiovascular Assessment Study
Kirsten E Peters1,2, Jialin Xu3, Scott D Bringans1
1Proteomics International, Nedlands, WA 6009, Australia.
Insights
A new blood test, PromarkerD, shows promise in predicting chronic kidney disease (CKD) in people with type 2 diabetes. High-risk scores on the PromarkerD test were significantly associated with developing incident CKD.
Area of Science:
- Nephrology
- Endocrinology
- Biomarker Discovery
Background:
- Predicting chronic kidney disease (CKD) in diabetic patients remains challenging with current diagnostic tools.
- Type 2 diabetes is a leading cause of CKD, necessitating improved prognostic methods.
- The CANagliflozin CardioVascular Assessment Study (CANVAS) provided a valuable cohort for investigating predictive biomarkers.
Purpose of the Study:
- To evaluate the prognostic utility of the novel blood test, PromarkerD, for predicting incident CKD in individuals with type 2 diabetes.
- To assess PromarkerD's ability to predict future decline in renal function (eGFR).
- To validate PromarkerD's performance within the multi-center CANVAS clinical trial.
Main Methods:
- PromarkerD scores were calculated at baseline for 3568 participants in the CANVAS study using mass spectrometry and clinical data.
- Participants were categorized into low-, moderate-, and high-risk groups based on their PromarkerD scores.
- Incident CKD and estimated glomerular filtration rate (eGFR) decline were monitored over 4 years of follow-up.
Main Results:
- Higher PromarkerD risk categories (moderate and high) were significantly associated with increased odds of developing incident CKD (OR 5.29 and 13.52, respectively; p < 0.001).
- The PromarkerD test demonstrated prognostic value for incident CKD in this large, multi-center study.
- The test showed limited utility in predicting a ≥30% decline in eGFR over the study period.
Conclusions:
- The PromarkerD blood test is a valuable tool for predicting the onset of chronic kidney disease in patients with type 2 diabetes.
- PromarkerD risk stratification can aid in identifying individuals at higher risk for CKD progression.
- Further research may be warranted to refine PromarkerD's predictive capabilities for specific renal function decline metrics.
Abstract:
The ability of current tests to predict chronic kidney disease (CKD) complicating diabetes is limited. This study investigated the prognostic utility of a novel blood test, PromarkerD, for predicting future renal function decline in individuals with type 2 diabetes from the CANagliflozin CardioVascular Assessment Study (CANVAS). PromarkerD scores were measured at baseline in 3568 CANVAS participants (n = 1195 placebo arm, n = 2373 canagliflozin arm) and used to predict incident CKD (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 during follow-up in those above this threshold at baseline) and eGFR decline ≥30% during the 4 years from randomization. Biomarker concentrations (apolipoprotein A-IV (apoA4), CD5 antigen-like (CD5L/AIM) and insulin-like growth factor-binding protein 3 (IGFBP3) measured by mass spectrometry were combined with clinical data (age, serum high-density lipoprotein (HDL)-cholesterol, eGFR) using a previously defined algorithm to provide PromarkerD scores categorized as low-, moderate- or high-risk. The participants (mean age 63 years, 33% females) had a median PromarkerD score of 2.9%, with 70.5% categorized as low-risk, 13.6% as moderate-risk and 15.9% as high-risk for developing incident CKD. After adjusting for treatment, baseline PromarkerD moderate-risk and high-risk scores were increasingly prognostic for incident CKD (odds ratio 5.29 and 13.52 versus low-risk, respectively; both p < 0.001). Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.
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