ASN's Mission

ASN leads the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on Twitter

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

Authors

  • 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
Background

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).

Methods

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.

Results

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.

Conclusion

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