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Kidney Week

Abstract: FR-OR113

Multicentre Prospective Validation of a Urinary Peptidome-Based Classifier for the Diagnosis of Type 2 Diabetic Nephropathy

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical


  • Tofte, Nete, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • Lindhardt, Morten, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • Currie, Gemma, University of Glasgow, Glasgow, United Kingdom
  • Frimodt-Moller, Marie, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • von der Leyen, Heiko E., Hannover Medical School, Hannover, Germany
  • Delles, Christian, University of Glasgow, Glasgow, United Kingdom
  • Mischak, Harald, Mosaiques Diagnostics, Sehnde, Germany
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Gentofte, Denmark

Group or Team Name

  • PRIORITY Study Group

Diabetic kidney disease (DKD) is a major late complication of diabetes. The 'Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria trial' (PRIORITY) is the first prospective study to evaluate the early detection of DKD in subjects with type 2 diabetes (T2D) and normal urinary albumin creatinine ratio (UACR) (<30 mg/g) using a urinary proteome-based classifier (CKD273).


Prospective multicentre observational study. The CKD273 classifier was assessed at baseline. The primary endpoint was development of confirmed microalbuminuria (moderate albuminuria) in 2 of 3 first morning urine samples (UACR >30 mg/g and with ≥30% increase (geometric mean) from baseline). For subjects with estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73m2 at baseline, development of CKD3: eGFR <60 ml/min/1.73m2 was a secondary outcome. Mean follow-up time was 2.57 years with a minimum of 7 days and a maximum of 4.33 years.


A total of 1775 participants from 15 centres were included, with 12 % (n=216) of these having a high-risk proteomic pattern. At baseline, participants in the high-risk group were more likely to be men, were older, had longer diabetes duration, lower eGFR and higher UACR than those in the low-risk group (n=1559, p<0.02). Numerical differences were small and univariate regression analyses showed weak associations (R2<0.04) of CKD273 with each baseline variable. Development of persistent microalbuminuria was seen in 28% of high risk and 8.9% of low risk subjects (p<0.0001), resulting in a hazard ratio (HR (95% CI)) of 3.924 (2.902-5.304) in a crude Cox-model; and 2.441 (1.766-3.374, p<0.0001) when adjusted for baseline age, sex, diabetes duration, HbA1c, systolic blood pressure, retinopathy, eGFR and UACR. For development of CKD3, HR (high vs. low risk) was 3.932 (2.811 – 5.499) in a crude model; and 4.089 (2.878 – 5.811, p<0.0001) adjusted.


In normoalbuminuric subjects with T2D, the urinary proteomic classifier CKD273 prospectively predicts progression to microalbuminuria and impaired renal function, independent of clinical characteristics.