Observational Study to Determine Reference Ranges for Novel Renal Biomarkers in Healthy Volunteers

• Activity Number: 542
• Type: Invited
• Date/Time: Wednesday, August 1, 2012 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jaromir Mikl*+
• Companies: Boehringer Ingelheim Pharmaceuticals, Inc.
• Keywords: renal urine biomarkers ; observational study ; reference range

Abstract

The PSTC conducted a non-intervention, three-week observational study of healthy volunteers providing urine samples used to measure renal biomarkers. Planned analysis includes non-parametric, robust, and bootstrap statistical methods to identify the appropriate reference intervals for each biomarker in the study population and will be done on 'raw' as well as normalized (to uCr levels) data. All analyses excludes subjects with = 25% increase in serum creatinine over the course of the study, to ensure that all subjects included in the analysis have stable kidney function. The goal of this study is to define reference ranges of renal urine biomarkers among healthy volunteers, to assess the impact of age, sex, food intake, time of day, and to characterize the mean values and inter- and intra-subject variability of measured renal biomarkers. Results from a total of 80 healthy subjects enrolled in the study will be presented and challenges in carrying out this observational study will be discussed.