NCT07408076

Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Stones, Urolithiasis, Hypocitraturia
• Nephrolithiasis

Interventions

Type	Name	Description
DRUG	Potassium Citrate	20 mEq Kcit twice a day (40 mEq daily
DRUG	Sodium Bicarbonate	650 mg sodium bicarbonate twice a day (35.2 mEq daily)

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-08-01
• Completion: 2028-02-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

6 sites across 3 countries: United States, Canada, Iceland

Regulatory

• FDA-regulated drug study