Regents of the University of Colorado Aurora United States
The primary goal of this application is to determine the efficacy of pravastatin therapy in slowing progression of kidney disease in patients with autosomal dominant polycystic kidney disease ADPKD. Subject recruitment is ongoing and to date 73 subjects have been randomized to treatment arm and have completed the baseline assessments. Baseline visits for 5 additional subjects have been scheduled and 3 additional subjects have been pre-screened and their visits are currently being scheduled for an overall total of N 81 subjects. Recruitment continues and the first subjects 2-year end of study visit will occur in mid-December 2019. There have been no additional screen failures beyond 2 reported in the previous annual report. There has been no drug related serious adverse events and the study is continuing. In a cross-sectional analysis of baseline data from 45 subjects, both peak and minimum renal blood flow rates significantly correlated with measured GFR. This suggests that early alteration in hemodynamic measures may be useful biomarkers of kidney function in early stage ADPKD. An abstract describing this data has been submitted to the 2019 American Society of Nephrology annual meeting scheduled for November.