Aim and purpose
The expenditure on people with diabetes accounts for 15% of the European health care budget. A significant part of these costs are associated with diabetic kidney disease which accounts for up to 45% of end stage renal disease.
With this project, we aim to confirm that the urinary proteome test identifies normoalbuminuric type 2 diabetes patients with a high risk for development of microalbuminuria.
We will demonstrate the clinical utility of the test by showing that aldosterone blockade in high-risk patients can reduce progression to microalbuminuria in comparison to placebo, on the top of standard treatment.
Design and method
PRIORITY is a randomised, double-blind, placebo-controlled, prospective multicentre study.
We will include 3,280 normoalbuminuric type 2 diabetes patients, who will be stratified into an observational group and an intervention group using the urinary proteomic test.
This research project targets type 2 diabetic patients with normoalbuminuria in 11 European countries.
Expected ending and outcome
The primary endpoint will be the development of confirmed microalbuminuria (Urine Albumin-to-Creatinine Ratio, UACR >30 mg/g) in at least two out of three urine tests, with at least 30% increase in UACR from the “run-in” period.
We will also examine changes in albuminuria in all patients throughout the study period by assessing the slope of albuminuria changes and absolute changes from inclusion to the end of study (156 weeks).
We will compare the observational group and the treated intervention group in order to assess the predictive value of the urinary proteomics test. Furthermore, within the intervention group, we will compare changes in albuminuria between patients randomised to placebo or the mineralocorticoid receptor antagonist spironolactone. The analysis will consider age and gender effects on the predictive value of the proteomics test and treatment effect.
Funding and collaborators
This project is funded by the EU’s Seventh Framework Programme (FP7).
The PRIORITY Consortium consists of 15 partners:
• Steno Diabetes Center, Denmark
• Mosaiques Diagnostics GmbH, Germany
• University Medical Center Groningen, The Netherlands
• University of Glasgow, United Kingdom
• Istituto di Richerche Farmacologiche Mario Negri, Italy
• Universita Karlova v Praze, Czech Republic
• Charité - Universitätsmedizin Berlin, Germany
• Geniko Nosokomeio Athinas Ippokrateio, Hospital Diabetes Center, Greece
• Institut Klinické a Experimentální Mediciny, Czech Republic
• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Spain
• Institut Universitaire de Recherche Clinique, France
• Klinikum St. Georg gGmbH, Germany
• Universität Zürich, Switzerland
• Cyril and Methodius University in Skopje, Former Yugoslav Republic of Macedonia
• Hannover Clinical Trial Center GmbH, Germany
The PRIORITY Consortium’s website: http://www.eu-priority.org/