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Abstract: PO0737

A Comparison of PromarkerD to Standard-of-Care Tests for Predicting Renal Decline in Type 2 Diabetes

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Peters, Kirsten E., Proteomics International, Perth, Western Australia, Australia
  • Bringans, Scott David, Proteomics International, Perth, Western Australia, Australia
  • Davis, Wendy A., The University of Western Australia Medical School, Perth, Western Australia, Australia
  • Lipscombe, Richard, Proteomics International, Perth, Western Australia, Australia
  • Davis, Timothy, The University of Western Australia Medical School, Perth, Western Australia, Australia
Background

Diabetic kidney disease (DKD) can progress to end stage renal disease with associated increased morbidity and mortality. Current standard of care (SoC) for assessing DKD includes measurement of estimated glomerular filtration rate (eGFR) and urinary albumin:creatinine ratio (ACR), but both tests have limitations. This study compared the biomarker-based PromarkerD test with SoC for predicting renal decline in community-based patients with T2D.

Methods

Baseline plasma biomarkers (CD5L, ApoA4, IGFBP3) measured by mass spectrometry were combined with clinical data (age, serum HDL-cholesterol, eGFR) using a validated algorithm to provide PromarkerD scores categorized as low, moderate or high risk in 857 participants with T2D from the Fremantle Diabetes Study Phase II. The 1° endpoint was incident DKD (reduction in eGFR to <60 mL/min/1.73m2 during follow-up) or eGFR decline ≥30% in participants with baseline eGFR <60 mL/min/1.73m2. Logistic regression was used to compare the association of i) PromarkerD, ii) eGFR, iii) ACR, and iv) eGFR+ACR, with outcomes during 4 years of follow-up. Model performance was assessed by the ROC area under the curve (AUC).

Results

At baseline, participants (mean age 65 years, 54% males, median diabetes duration 7 years) had mean eGFR 82 mL/min/1.73m2, geometric mean ACR 26 mg/g and were classified by PromarkerD as low (63%), moderate (13%) or high risk (24%) for renal decline. During 4.2±0.3 years of follow-up, 107 (13%) participants reached the 1° endpoint. PromarkerD had significantly higher predictive performance (AUC=0.88) compared to eGFR (0.82), ACR (0.63) and eGFR+ACR (0.82) (all P<0.001). Higher PromarkerD scores had a stronger association with the 1° outcome (odds ratio (OR) 3.26, 95% CI 2.67-3.99 per 1 standard deviation (SD) increase) compared to lower eGFR and higher ACR (OR=2.63 (2.13-3.23) and 1.21 (1.04-1.40) per 1 SD increase, respectively). PromarkerD remained significantly associated with the 1° outcome after adjusting for eGFR and ACR (OR=2.78 (2.19-3.53) per 1 SD increase). PromarkerD moderate and high-risk scores were increasingly prognostic for the 1° outcome (OR 8.11 and 21.34 versus low risk, respectively; both P<0.001).

Conclusion

PromarkerD outperformed the standard of care tests eGFR and ACR for predicting future renal decline in T2D.

Funding

  • Commercial Support – Proteomics International