Next-Generation PromarkerD vs. Standard of Care for Assessing Kidney Function Decline in Type 2 Diabetes

Introduction and Objective: Diabetic kidney disease (DKD) can progress to end-stage kidney disease, increasing morbidity and mortality. Standard DKD assessment using estimated glomerular filtration rate (eGFR) and urinary albumin:creatinine ratio (ACR) has limitations in early risk prediction. This study compared the Promarker®D test to eGFR and ACR for predicting kidney function decline over 4 years in adults with type 2 diabetes (T2D). Methods: Next-generation PromarkerD, optimized for ELISA-based workflows, integrates plasma apolipoprotein A-IV and CD5 antigen-like protein with age and eGFR to generate risk scores (low, moderate, high). The study analyzed data from the Fremantle Diabetes Study (n=948; mean age 65 years, 54% males). The 1° endpoint was incident DKD (an eGFR drop to <60 mL/min/1.73m² or a ≥40% decline from baseline eGFR <60 mL/min/1.73m²). Logistic regression models assessed the association of i) PromarkerD, ii) eGFR, iii) ACR, and iv) eGFR + ACR with the 1° outcome. Model performance was evaluated using the area under the curve (AUC). Results: At baseline, mean eGFR was 82 mL/min/1.73m², median ACR 2.1 mg/mmol. PromarkerD classified 65% as low, 24% moderate, and 11% high risk. Over 4.2 years, 11.3% reached the 1° endpoint. PromarkerD had superior predictive performance (AUC 0.88) vs. eGFR (0.80), ACR (0.63), and eGFR + ACR (0.81) (P<0.001). Higher PromarkerD scores were more strongly associated with the 1° outcome (odds ratio (OR) 3.14, 95% CI 2.60-3.79 per 1 standard deviation (SD) increase) than lower eGFR and higher ACR (OR 2.30 (1.90-2.79) and 1.29 (1.12-1.49) per 1 SD increase, respectively). PromarkerD moderate and high-risk scores were increasingly prognostic (OR 4.52 and 17.87 vs. low risk; P<0.001). PromarkerD remained significantly associated with the 1° outcome after adjusting for eGFR and ACR (OR 2.88 (2.31-3.58) per 1 SD increase). Conclusion: Next-generation PromarkerD more accurately identifies adults with T2D at risk of kidney function decline than current standard of care biochemical tests. Disclosure: K.E. Peters: Employee; Proteomics International. Stock/Shareholder; Proteomics International. Other Relationship; Proteomics International. S. Bringans: Employee; Proteomics International. Stock/Shareholder; Proteomics International. Other Relationship; Proteomics International. W.A. Davis: Other Relationship; Proteomics International. R.J. Lipscombe: Employee; Proteomics International. Stock/Shareholder; Proteomics International. T. Davis: Speaker's Bureau; Novo Nordisk A/S. Research Support; Eli Lilly and Company.