Using sodium bicarbonate to change 24-hour urine measurements in people with low urine citrate or uric acid kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study at the University of California, Irvine will switch eligible adults from potassium citrate (Urocit-K) to sodium bicarbonate and measure changes in 24-hour urine chemistry. Participants are adults with hypocitraturia (<320 mg/24 h) who form calcium oxalate or uric acid stones and are already on Urocit-K. The trial compares urinary citrate, urine pH, and other 24-hour urine parameters before and after the intervention. The protocol excludes people with reduced kidney function, diabetes, certain GI or metabolic disorders, pregnancy, or those taking thiazides or ACE inhibitors.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California, Irvine Medical Center
  Orange, California, United States Recruiting

Study contacts

• Principal investigator: Sohrab N Ali, M.D — University of California, Irvine
• Study coordinator: Sohrab N Ali, M.D
• Email: sohrabna@hs.uci.edu
• Phone: 7145062352

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.