Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
study ends around

Description

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.

Details

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.

Keywords

Kidney Stones, Urolithiasis, Hypocitraturia, Nephrolithiasis, kidney stone, stone, calcium oxalate, calcium phosphate, potassium citrate, sodium bicarbonate, Kidney Calculi, Urolithiasis, Calculi, Sodium Bicarbonate -> Potassium Citrate, Potassium Citrate -> Sodium Bicarbonate

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, San Diego
    San Diego California 92103 United States
  • University of California, Los Angeles
    Los Angeles California 90095 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07408076
Phase
Phase 1/2 Kidney Stones Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated