Role of Medication in Making Urine Less Acidic as Part of Kidney Stone Prevention

NCT06819111 | Not Yet Recruiting Phase 1

• 1 other identifier: STU-2024-1257
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diet and medications are the cornerstones of kidney stone prevention. Potassium citrate is a commonly prescribed medication to help prevent kidney stones by making urine less acidic. There are different forms of potassium citrate such as over-the-counter tablet or powder, and slow-release tablets that require a prescription. However, it is unknown if one form is better than the others. Therefore, we want to compare different forms of potassium citrate and find out how well they work and whether patients prefer one form over the others. The study period will last approximately 6 weeks for each participant. Patients will be instructed to take one form of potassium citrate for one week at a time followed by a washout period for one week. This process will be completed a total of three times as we seek to study the effects of three forms of potassium citrate. At the end of each trial week patients will be asked to provide urine samples and complete two surveys. Urine will need to be collected for 24 hours, which will then be examined to determine the effects that each form of potassium citrate has on urine. In addition, completed surveys will give us information on how well the medication was tolerated and their satisfaction with the treatment. There is a possibility that patients like one form better than others, and it is also possible that they do not see a difference at all. Throughout the duration of the study patients will be asked to be a directed diet. This will be based on general recommendations by the National Kidney Foundation for the prevention of kidney stones.

Conditions

Kidney Calculi

Keywords

kidney stone prevention; potassium citrate; urine alkalization

Outcome Measures

Primary Outcomes (1)

• Urinary pH

  Change in urinary pH and urinary citrate

  From enrollment to the end of treatment at 6 weeks.

Study Arms (1)

Urine Alkalization

EXPERIMENTAL

In this crossover study, patients will serve as their own controls. Patients will receive slow-release potassium citrate (UroCit-K), potassium magnesium citrate (powder), or potassium magnesium citrate (tablets). The study period will last approximately 6 weeks for each participant. Patients will be instructed to take one form of potassium citrate for one week at a time followed by a washout period for one week. This process will be completed a total of three times as we seek to study the effects of three forms of potassium citrate.

Drug: Potassium Citrate Extended Release Oral Tablet

Interventions

Potassium Citrate Extended Release Oral Tablet DRUG

In this crossover study, patients will serve as their own controls. Patients will receive slow-release potassium citrate (UroCit-K), potassium magnesium citrate (powder), or potassium magnesium citrate (tablets). The study period will last approximately 6 weeks for each participant. Patients will be instructed to take one form of potassium citrate for one week at a time followed by a washout period for one week. This process will be completed a total of three times as we seek to study the effects of three forms of potassium citrate.

Also known as: potassium magnesium citrate (powder), potassium magnesium citrate (tablets)

Urine Alkalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults, 18 years or older
• recurrent stone formers or first-time stone formers at high risk for recurrence
• have a baseline 24-hour urine within six months from study enrollment
• have the ability to adhere to a directed diet

You may not qualify if:

• minors (age \<18 years)
• mentally incapacitated and/or unable to provide consent
• prisoners
• pregnant or breastfeeding individuals
• concurrent potassium citrate therapy
• concurrent thiazide therapy
• chronic kidney disease (eGFR \<60)
• solitary kidney
• unable to take any of the study medications due to a prior adverse reaction or other health-related reason (ex: severe renal impairment, hyperkalemia, or severe acidosis or alkalosis).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Kidney Calculi

Interventions

potassium-magnesium citrate; Powders; Tablets

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Isaac D Palma-Zamora, MD

CONTACT

214-645-8765; isaac.palma-zamora@utsouthwestern.edu

Brett A Johnson, MD

CONTACT

214-645-8765; brett.johnson@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The crossover design of our study was intentional to allow patients to serve as their own controls across multiple study arms.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 11, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share