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About
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.
Enrollment
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Inclusion criteria
Male or female, ≥ 18 years of age (inclusive) at time of screening
Diagnosis of one of the following:
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
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
36 participants in 3 patient groups
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Central trial contact
Trinity Hooks; Taylor Cunningham
Data sourced from clinicaltrials.gov
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