PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration


About this study

The objectives of this study are to evaluate the effectiveness and safety of PB in the treatment of patients with hereditary nephrogenic diabetes insipidus, to evaluate the effectiveness and safety of PB in polyuric patients with autosomal dominant polycystic kidney disease treated with tolvaptan, and to evaluate the effectiveness and safety of PB in polyuric patients previously treated with lithium.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Diagnosis of nephrogenic diabetes insipidus (NDI) (congenital, tolvaptan-induced, or

- 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated12/20/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Fouad Chebib, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information


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