NCT06335537 Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers
| NCT ID | NCT06335537 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, Irvine |
| Condition | Uric Acid Stones |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-05-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The incidence of kidney stone disease continues to rise globally. Although the treatment of kidney stone disease has dramatically improved in recent years, surgical management remains invasive and expensive. Patients who develop kidney stones are at high risk of recurrence during their lifetime; therefore, prevention of stones should be a primary focus. Low levels of citrate and acidic urine are risk factors for the formation of kidney stones such as calcium oxalate and uric acid, respectively. Calcium oxalate stones are the predominant stone composition in the United States, accounting for over 2/3rds of stones. Citrate is a key inhibitor of calcium oxalate crystal formation and thus increasing it in the urine of a calcium oxalate stone former is quite beneficial. Uric acid stones account for approximately 10 percent of all stone types. These stones form primarily due to an acidic urinary environment which is a prerequisite for crystal formation. Common medications for stone formers include potassium citrate which help to make the urine more alkaline. Although effective, these medications have side effects and may prove to be too expensive (upwards of $450/month). Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary citrate levels and alkalinizing the urine. Investigators hypothesize that twice a day oral baking soda in a liquid medium (e.g., water, orange juice, soda, etc.) can be an effective, and inexpensive alternative to urocit K with regard to alkalinizing the urine and raising urinary citrate levels.
Eligibility Criteria
Inclusion Criteria: * \> 18 years of age and \< 80 years of age, * Hypocitriuric (\<320 mg/24 hours), Calcium Oxalate Stone or Uric Acid stone formers, currently on Urocit-K therapy as the standard of care. Exclusion Criteria: * Male or female \<18 years old or \> 80 years old. * Currently taking thiazides or ACE inhibitor medications * Pregnant women. * Women who are breastfeeding or plan to breastfeed during study period * History of abnormal renal function (defined as eGFR \<60 mL/min/1.73 m2), active urinary tract infection, diabetes, cystinuria, renal tubular acidosis, inflammatory bowel disease, chronic diarrhea, primary hyperparathyroidism, peptic ulcer disease.
Contact & Investigator
Ralph V Clayman, MD
STUDY DIRECTOR
University of California, Irvine
Frequently Asked Questions
Who can join the NCT06335537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Uric Acid Stones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06335537 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06335537 currently recruiting?
Yes, NCT06335537 is actively recruiting participants. Contact the research team at sohrabna@hs.uci.edu for enrollment information.
Where is the NCT06335537 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT06335537 clinical trial?
NCT06335537 is sponsored by University of California, Irvine. The principal investigator is Ralph V Clayman, MD at University of California, Irvine. The trial plans to enroll 100 participants.