Baseline Characteristics in PRIORITY Study: Proteomics and Mineralocorticoid Receptor Antagonism for Prevention of Diabetic Nephropathy in Type 2 Diabetes

Background In PRIORITY (Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria) the aim is to test if the urinary proteomics based classifier CKD273 can predict microalbuminuria prospectively, and to test whether mineralocorticoid receptor antagonism (MRA) delays progression to microalbuminuria. Methods Prospective, randomized, double-blind, placebo-controlled multicentre clinical trial and observational study in normoalbuminuric type 2 diabetic patients. Patients are stratified into high- or low risk groups based on CKD273. Patients in the high risk group are assigned to spironolactone 25 mg once daily or placebo, the low-risk group is followed on standard care. Patients are followed for up to 4.5 years. Primary endpoint is development of microalbuminuria. Results From 15 sites we have included 1811 patients. The high- and low-risk populations differ in terms of gender, age, diabetes duration, UACR and eGFR (table). Univariate regression analyses of CKD273 vs each baseline variable demonstrated weak associations (R2 of 0.03, p <0.0001) for the strongest correlations with UACR and eGFR. In a logistic regression model predicting CKD273 risk strata, including all baseline variables, eGFR and UACR remain statistically significant (p < 0.0003) with an AUC of 0.70 (95 % CI: 0.65, 0.74). Conclusion Classical risk factors for diabetic kidney disease differ only slightly, and overlap to a great extent, between high and low risk patients based on the urinary proteomics based risk classifier CKD273 in type 2 diabetes, suggesting it provides additional information to the measures already available in the clinic. The potential added value will be tested in this prospective study.