| Registry | NCT07408076 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | University of California, Los Angeles (Other); collaborators: University of California, Davis, Brigham and Women's Hospital, Landspitali University Hospital, University of California, San Diego, Centre hospitalier de l'Université de Montréal (CHUM) |
| Conditions | Kidney Stones, Urolithiasis, Hypocitraturia, Nephrolithiasis |
| Interventions | Potassium Citrate, Sodium Bicarbonate (Drug) |
| Dates | start 2026-02-01 (estimated), primary completion 2026-08-01 (estimated), completion 2028-02-01 (estimated), first posted 2026-02-12, last updated 2026-02-12 |
| Locations | 6 sites in United States, Canada, Iceland |
Related Papers Related Patents Related Grants Related Experts
All trials for Kidney Stones, Urolithiasis, Hypocitraturia All trials for Nephrolithiasis All trials of Potassium Citrate All trials of Sodium Bicarbonate
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sodium Bicarbonate -> Potassium Citrate | Experimental | Drug: Potassium Citrate; Drug: Sodium Bicarbonate | Receives 1 week of sodium bicarbonate, then 1 week of potassium citrate after washout. |
| Potassium Citrate -> Sodium Bicarbonate | Experimental | Drug: Potassium Citrate; Drug: Sodium Bicarbonate | 1 week of potassium citrate first, then sodium bicarbonate after a washout. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of California, Los Angeles | Los Angeles, California | United States | |
| University of California, Davis | Sacramento, California | United States | |
| University of California, San Diego | San Diego, California | United States | |
| Brigham & Women's | Boston, Massachusetts | United States | |
| CHUM | Montreal | Canada | |
| Landspitali- National University Hospital of Iceland | Reykjavik | Iceland |