Diabetes-related chronic kidney disease (DKD) is a leading cause of end-stage kidney disease, often requiring costly dialysis or kidney transplantation. Existing standard of care tests have limitations, highlighting the need for earlier, reliable prognostic tools. Promarker®D is a validated plasma proteomic test that predicts DKD in adults with type 2 diabetes up to four years before symptoms develop. While PromarkerD has shown strong predictive performance in Caucasian populations, its accuracy in other racial and ethnic groups has not been fully characterised.
The PromarkerD test measures two protein biomarkers, apolipoprotein A-IV and CD5 antigen-like, combined with age and estimated glomerular filtration rate to classify individuals into low, moderate or high risk for DKD.
PromarkerD performance was first evaluated in a community cohort of 1,081 adults with diabetes from the Fremantle Diabetes Study, comprising 1,010 non-Aboriginal and 71 Aboriginal participants. The test demonstrated strong discrimination for predicting DKD, with area under the receiver operating characteristic curves (AUCs) of 0.89 for non-Aboriginal participants and 0.71 for Aboriginal participants, with no statistically significant difference. Despite the smaller Aboriginal sample, PromarkerD retained meaningful predictive value, suggesting potential clinical utility in Indigenous populations where DKD burden is high. Further evaluation across additional racial and ethnic groups was undertaken in a post-hoc analysis of 1,201 participants from the CANVAS clinical trial including White, Asian, African American and Hispanic/Latino.
Preliminary findings suggest PromarkerD is a clinically generalisable tool for identifying individuals at risk of DKD across diverse populations.