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NCT Number: NCT07408076

Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones

Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications.

Prescription potassium citrate can be expensive for many patients, leading to non-compliance. Sodium bicarbonate is a potential medication alternative that is cheaper and can potentially alkalinize the urine and/or decrease the risk of future kidney stones. However, efficacy of alternatives to potassium potassium citrate are not well studied.

This study seeks to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of patients with kidney stones and compare this to prescription potassium citrate.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CHUM, Montreal, Canada

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About this study

Kidney stones affect 1 in every 11 people in the United States each year. A recurrence rate of 50% at 10 years highlights the importance of metabolic management, which has shown to be effective at decreasing the recurrence of stone disease. Specialty guidelines have recommended that clinicians offer pharmacologic therapy to recurrent stone formers. However, among kidney stone patients prescribed medication for stone management, only 30.2% are adherent to a medication regimen and even fewer, only 13.4%, are adherent with citrate medications.

Prescription potassium citrate (Kcit) can be cost-prohibitive for many patients, leading to non-compliance. The combination of the effectiveness of medication with the prohibitory cost of the prescriptions has led to the exploration of treatment alternatives which promise to alkalinize the urine and/or decrease the risk of future kidney stones, including sodium bicarbonate. However, the efficacy of these alternatives in comparison to Kcit are not well studied and often include other alkali equivalents.

A short-term study with limited sample size suggests sodium bicarbonate to be a viable alternative to Kcit. Our goal is to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of stone-forming patients and compare this to prescription Kcit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult >18 years of age
  • History of nephrolithiasis
  • One 24h urine collections within one year of enrollment with hypocitraturia.
  • Patients currently utilizing or considering use of Kcit for stone prevention

Exclusion criteria

  • Individuals with known metabolic disorders
  • Individuals with other known causes of nephrolithiasis
  • Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study

Treatment and study plan

potassium citrate

Drug

20 mEq Kcit twice a day (40 mEq daily

Sodium bicarbonate

Drug

650 mg sodium bicarbonate twice a day (35.2 mEq daily)

Primary outcomes

  1. Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection

    Time frame: 14 days

    Change in 24-hour urinary citrate excretion measured from 24-hour urine collections obtained at baseline and after intervention.

    To determine if sodium bicarbonate is not significantly worse than potassium citrate by more than a clinically acceptable margin of -10

    Unit: mg/day

Secondary outcomes

  1. Change in Urine pH Measured from 24-Hour Urine Collection

    Time frame: 14 days

    Change in urine pH measured from 24 hour urine collections obtained at baseline and after intervention

    units: pH

  2. Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection

    Time frame: 14 days

    Change in 24 hour urinary ammonia excretion from 24 hour urine collections obtained at baseline and after intervention

    Unit: mmol/day

Other outcomes

  1. Incidence of Side Effects

    Time frame: 14 days

    Number of participants experiencing side effects attributed to the intervention

    Unit: number of participants with ≥1 adverse event

Study contacts

Contact information is provided by the study sponsor or research team.

Janelly B Jimenez

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Brigham and Women's Hospital
  • Centre hospitalier de l'Université de Montréal (CHUM)
  • Landspitali University Hospital
  • University of California, Davis
  • University of California, San Diego

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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