PB to reduce increased urination related to tolvaptan therapy in patients with ADPKD

Jacksonville, Duval County, Florida, United States

Overview
The purpose of this research is to study the effectiveness and safety of the medication PB in slowing the frequent urination related to tolvaptan as long-term treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD), or frequent urination related to inherited nephrogenic diabetes insipidus as an inherited condition or as an acquired condition from prior treatment with lithium.

Inclusion Criteria

    • Ages 18 years and older
    • GFR ≥ 30 ml/min.
    • Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    • Morning Uosm < 300 mOsm/kg H2O

Additional inclusion/exclusion criteria will apply

Participation

Participation will include taking 500mg of PB twice daily, followed by taking 1000mg of PB twice daily. This will be continued for up to three months. Urine osmolality samples will be collected at each visit, and a 24 hour urine sample will be collected at baseline, Day 15, Day 45, & Day 75.

Locations

Florida