A Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine Output and Increasing the Urine Osmolality in Patients With Hereditary Nephrogenic Diabetes Insipidus, Patients With Autosomal Dominant Polycystic Kidney Disease Treated With Tolvaptan, And Severely Polyuric Patients With Previous Lithium Administration (Serendipity-PB1)
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.
• Male or female, ≥ 18 years of age (inclusive) at time of screening
• Diagnosis of one of the following:
‣ ADPKD(as delineated in cohort 1)
⁃ Congenital NDI (as delineated in cohort 1)
⁃ Lithium-induced NDI (as delineated in cohort 1)
• Glomerular filtration rate (GFR) ≥ 25 ml/min/1.73 m2 at time of screening visit calculated as in cohort
• 24 hours urine volume in baseline 1 visit ≥ 5000 ml/ day
• If hypertensive, blood pressure controlled on antihypertensives (\<130/80 mm Hg) at least 30 days before day 1. Antihypertensives may be adjusted at time of baseline 2 per PI discretion.
• Female participants (see details in cohort 1 inclusion criteria)
• Have read, understood, and provided written informed consent after the nature of the study has been fully explained and must be willing to comply with protocol requirements and study-related procedures.
• Negative urinary pregnancy test (if applicable) at baseline 2
• Capable of providing urine samples as dictated by the protocol