PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration (SerendipityPB1)
Autosomal Dominant Polycystic Kidney Disease, Nephrogenic Diabetes Insipidus, Acquired Nephrogenic Diabetes Insipidus
About this trial
This is an interventional supportive care trial for Autosomal Dominant Polycystic Kidney Disease focused on measuring Tolvaptan, ADPKD, Polycystic Kidney Disease, NDI, Nephrogenic diabetes insipidus, Inherited nephrogenic diabetes insipidus, Diabetes Insipidus, Lithium, Lithium-induced nephrogenic diabetes insipidus, Vasopressin receptor antagonist, Tolvaptan-induced aquaresis
Eligibility Criteria
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 ≥ 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.
Sites / Locations
- Mayo ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Polyuric subjects with Hereditary Nephrogenic Diabetes Insipidus
Polyuric subjects with Autosomal Dominant Polycystic Kidney Disease treated with Tolvaptan
Polyuric subject secondary to lithium administration
Polyuric subjects with hereditary nephrogenic diabetes insipidus with loss of function of AVPR2 or AQP2 will be treated with PB
Polyuric subjects with autosomal dominant polycystic kidney disease on chronic tolvaptan treatment will be treated with PB
Polyuric subject post lithium administration will receive PB