Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria: (PRIORITY) study
Gemma Currie, MBChB, MRCP
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK Morten Lindhardt, MD, PhD
McMaster University & Hamilton Health Sciences, Hamilton, Canada
A specific risk classifier based on urinary proteomics (chronic kidney disease (CKD)273) has been shown to identify normoalbuminuric patients with diabetes who later progressed to overt kidney disease, and may hold the potential for selection of high-risk patients for early intervention. Combining the ability of CKD273 to identify patients at highest risk of progression with prescription of preventive aldosterone blockade only in this high-risk population may increase this power.
The PRIORITY study investigated the ability of CKD273 to predict the development of microalbuminuria in patients with type 2 diabetes and determined whether early intervention with spironolactone can reduce the risk of developing microalbuminuria.
Investigator-initiated, prospective multicentre clinical trial, with randomised double-masked placebo-controlled intervention in high-risk patients and a prospective observational phase in low-risk patients.
Risk was determined by classification with CKD273.
High-risk patients were randomised to placebo or spironolactone.
Type 2 diabetes with preserved renal function (estimated glomerular filtration rate (eGFR) >45 mL/min/1.73 m2) and normoalbuminuria (urine albumin to creatinine ratio (UACR) <30 mg/g in two of three consecutive morning urine samples).
1775 patients were screened (216 high-risk patients for randomisation and 1559 low-risk participants for observation).
The primary outcome was development of confirmed microalbuminuria in 2 of 3 first morning voids urine samples with at least a 30% increase from run-in samples or 40 mg/g.