COMPLETED

Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

Conditions

Kidney Stones Nephrolithiasis Prevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.

Official Title

Randomized Trial of Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

Quick Facts

Study Start:2022-08-04

Study Completion:2025-10-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05365477

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Two or more symptomatic kidney stone events in the last 5 years * Adult	* Medullary sponge kidney or renal tubular acidosis * Untreated urinary obstruction * Primary hyperparathyroidism * Primary hyperoxaluria * Pregnancy * Inflammatory bowel disease or bowel resection * Sarcoidosis * Cystinuria * Prior stone composition with uric acid, struvite, cystine, carbonate apatite * Use of specific medications (thiazides, topiramate, xanthine oxidase inhibitors, citrate, bicarbonate) * Chronic kidney disease stage 3 or higher (eGFR\<60) * Gouty arthritis or 3 gout episodes in 1 year * Known allergy to study medications * Hypokalemia or hyponatremia at screening. * Age \< 18 years

Inclusion Criteria

Exclusion Criteria

* Two or more symptomatic kidney stone events in the last 5 years
* Adult

* Medullary sponge kidney or renal tubular acidosis
* Untreated urinary obstruction
* Primary hyperparathyroidism
* Primary hyperoxaluria
* Pregnancy
* Inflammatory bowel disease or bowel resection
* Sarcoidosis
* Cystinuria
* Prior stone composition with uric acid, struvite, cystine, carbonate apatite
* Use of specific medications (thiazides, topiramate, xanthine oxidase inhibitors, citrate, bicarbonate)
* Chronic kidney disease stage 3 or higher (eGFR\<60)
* Gouty arthritis or 3 gout episodes in 1 year
* Known allergy to study medications
* Hypokalemia or hyponatremia at screening.
* Age \< 18 years

Contacts and Locations

Principal Investigator

Ryan Hsi, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Ryan Hsi, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-04

Study Completion Date2025-10-17

Study Record Updates

Study Start Date2022-08-04

Study Completion Date2025-10-17

Terms related to this study

Keywords Provided by Researchers

Prevention

Additional Relevant MeSH Terms

Kidney Stones
Nephrolithiasis