Autosomal Dominant Polycystic Kidney Disease Clinical Trial
— SerendipityPB1Official title:
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)
Verified date | April 2024 |
Source | Mayo Clinic |
Contact | Trinity Hooks |
Phone | 904-953-3057 |
Hooks.Trinity[@]mayo.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of nephrogenic diabetes insipidus (NDI) (congenital, tolvaptan-induced, or lithium-induced). - Morning Uosm < 300 mOsm/kg H2O. - Participating in tolvaptan arm. - Males for NDI. - Autosomal Dominant Polycystic Kidney Disease (ADPKD). - Lithium-induced NDI. - GFR (Glomerular filtration rate) = 30 ml/min. - If hypertensive, blood pressure controlled on antihypertensives (< 130/80 mm Hg) at least 30 days before day 1. - Capable of providing consent. - Capable of providing urine samples as dictated by the protocol. Exclusion Criteria: - History of acute gout attack in the past 30 days. - Uncontrolled hyperuricemia or active gout. - Known urinary retention, urinary incontinence or bladder dysfunction. - Other significant chronic medical disease (heart failure, diabetes mellitus, liver disease, transient or persistent elevated transaminases. - History of hepatotoxicity related to tolvaptan. - Allergy to interventional drug (PB). - History of persistent hyponatremia. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Hopital du Sacre-Coeur de Montreal |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in urine osmolality | Measured in milliosmoles per kilogram of water (mOsm/kg) from a urine specimen and is a measure of the concentration of osmotically active particles, principally sodium, chloride, potassium, and urea | Baseline, 90 days | |
Secondary | Change in urine output | Measured in milliliters per day (ml/day) by 24 hour urine collection | Baseline, day 15, day 45, day 75 |
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