AIM: To compare clinical baseline data in individuals with Type 2 diabetes and normoalbuminuria, who are at high or low risk of diabetic kidney disease based on the urinary proteomics classifier CKD273. METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled international multicentre clinical trial and observational study in participants with Type 2 diabetes and normoalbuminuria, stratified into high- or low-risk groups based on CKD273 score. Clinical baseline data for the whole cohort and stratified by risk groups are reported. The associations between CKD273 and traditional risk factors for diabetic kidney disease were evaluated using univariate and logistic regression analysis. RESULTS: A total of 1777 participants from 15 centres were included, with 12.3% of these having a high-risk proteomic pattern. Participants in the high-risk group (n=218), were more likely to be men, were older, had longer diabetes duration, a lower estimated GFR and a higher urinary albumin:creatinine ratio 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. In a logistic regression model including clinical variables known to be associated with diabetic kidney disease, estimated GFR, gender, log urinary albumin:creatinine ratio and use of renin-angiotensin system-blocking agents remained significant determinants of the CKD273 high-risk group: area under the curve 0.72 (95% CI 0.68-0.75; P<0.01). CONCLUSIONS: In this population of individuals with Type 2 diabetes and normoalbuminuria, traditional diabetic kidney disease risk factors differed slightly between participants at high risk and those at low risk of diabetic kidney disease, based on CKD273. These data suggest that CKD273 may provide additional prognostic information over and above the variables routinely available in the clinic. Testing the added value will be subject to our ongoing study. (European Union Clinical Trials Register: EudraCT 2012-000452-34 and Clinicaltrials.gov: NCT02040441).

1st Department Charles University 3rd Faculty of Medicine Prague Czech Republic

Amsterdam Public Health Research Institute VU University Medical Centre Amsterdam The Netherlands

Bethesda Diabetes Research Centre Hoogeveen and University Medical Centre Groningen Netherlands

Clinical Study Centre Metabolic Vascular Medicine GWT TU Dresden GmbH Dresden Germany

Department General Practice and Elderly Care Amsterdam Public Health VU University Medical Centre Amsterdam The Netherlands

Department of Nephrology Cyril and Methodius University in Skopje Skopje Macedonia

Diabetes Centre and 2nd Department of Internal Medicine National and Kapodistrian University of Athens Hippokratio General Hospital Athens Greece

Diabetes Centre Institute for Clinical and Experimental Medicine Prague Czech Republic

Diabetespraxis Leipzig Germany

Diabetologische Schwerpunktpraxis Diabetologen Hessen Marburg Germany

Division of Nephrology Department of Internal Medicine University Medical Centre Groningen Groningen Netherlands

Faculty Hospital Královské Vinohrady Prague Czech Republic

German Centre for Diabetes Research Neuherberg Germany

Ghent University Hospital Department of Nephrology Ghent Belgium

Hannover Clinical Trial Centre Hannover Germany

Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow UK

Instituto de Investigacion Sanitaria de la Fundacion Jiménez Díaz UAM Madrid Spain

Istituto di Richerche Farmacologiche Mario Negri Bergamo Italy

Julius Centre for Health Sciences and Primary Care University Medical Centre Utrecht Utrecht The Netherlands

Klinikum St Georg Nephrology and KfH Renal Unit Leipzig Martin Luther University Halle Wittenberg Germany

Mosaiques Diagnostics Hannover Germany

Paul Langerhans Institute Dresden of the Helmholtz Centre Munich at University Hospital and Faculty of Medicine TU Dresden Dresden Germany

Steno Diabetes Centre Copenhagen Gentofte Denmark

University Clinic of Endocrinology Diabetes and Metabolic Disorders Skopje Macedonia

University of Copenhagen Copenhagen Denmark

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ClinicalTrials.gov
NCT02040441