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

Description

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease, Nephrogenic Diabetes Insipidus, Acquired Nephrogenic Diabetes Insipidus, Congenital Nephrogenic Diabetes Insipidus

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Autosomal Dominant Polycystic Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Fouad Chebib, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-12-31