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Probenecid (PB) to Treat Hereditary Nephrogenic Diabetes Insipidus (NDI), ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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)

NCT05190744•Mayo Clinic

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, ≥ 18 years of age (inclusive) at time of screening
•Diagnosis of one of the following:
•1. ADPKD(as delineated in cohort 1)
•2. Congenital NDI (as delineated in cohort 1)
•3. Lithium-induced NDI (as delineated in cohort 1)
•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.
•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
+1 more criteria

Exclusion Criteria

•Advanced diabetes (e.g., glycosylated hemoglobin \[HgbA1c\] \>7.5%, and/or glycosuria by dipstick, significant proteinuria \[\>300 mcg albumin/mg creatinine\]), other significant kidney disease, kidney cancer, transplanted kidney, single kidney, kidney surgery within the past 6 months (including cyst drainage or fenestration) or acute kidney injury within 6 months prior to screening.
•Clinically significant incontinence, overactive bladder, or urinary retention (e.g., benign prostatic hyperplasia).
•Other significant chronic medical disease (heart failure, diabetes mellitus, liver disease, transient or persistent elevated transaminases)
•History of acute gout attack in the past 30 days
•History of clinically significant drug or alcohol abuse in the 2 years prior to screening visit.
•Uncontrolled hyperuricemia or active gout
•History of hepatotoxicity related to tolvaptan; or clinically significant liver disease or impairment; or alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin values \>1.2 x Upper Limit of Normal (ULN) during screening.
•Medical history or findings that preclude safe participation in the trial or participants who are likely to be non-compliant with trial procedures in the opinion of the investigator or medical monitor.
•Requirement for ongoing diuretic use.
•Participants who are currently taking, or are expected to be taking, strong or moderate CYP3A4 or CYP2C8 inhibitors or inducers including regular use of grapefruit juice, Seville oranges, or St. John's wort. If applicable, there should be a 14-day washout of these treatments prior to Day 1.
+7 more criteria

Locations (1)

Mayo Clinic

Jacksonville, Florida, United States

Key Dates

Start Date

September 1, 2022

Primary Completion Date

December 8, 2025

Completion Date

December 8, 2025

Last Updated

January 27, 2026

Enrollment

ACTUAL participants

Conditions

Autosomal Dominant Polycystic Kidney DiseaseNephrogenic Diabetes InsipidusAcquired Nephrogenic Diabetes InsipidusCongenital Nephrogenic Diabetes Insipidus

Interventions

DRUG

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

NCT07454174

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

View study

RECRUITING

National Registry of Rare Kidney Diseases

NCT06065852

Adenine Phosphoribosyltransferase DeficiencyAH Amyloidosis+82 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

National Registry of Rare Kidney Diseases

Autosomal Dominant Polycystic Kidney Disease Somatic Mutation Biorepository

A Possible Founding PKD2 Mutation Associated With Variable Phenotypes of ADPKD in Bergamo Province

Study of Tamibarotene in Patients With ADPKD

Bempedoic Acid Therapy for Polycystic Kidney Disease