Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Potassium citrate effects on kidney handling of oxalate and citrate in adults

Official title: Oxalate and Citrate in Humans - Response to Citrate

Run by University of Chicago · NCT06944223 · Data updated 2026-11-12

This project will test whether a single oral dose of potassium citrate changes how the kidneys handle oxalate and citrate in adults with and without calcium oxalate kidney stones.

More Kidney Stone trials

Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment24 (estimated)
SponsorUniversity of Chicago
Academic / other
Locations1 site (Chicago, Illinois)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedDecember 1, 2026
Study endsJune 1, 2027
Registry record updatedDecember 16, 2025
Trial IDNCT06944223 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–70 who either have at least one calcium-based kidney stone or have no stone history with normal 24‑hour urine oxalate, can stop diuretics/alkali for the study, and have preserved kidney function are ideal candidates.

Probably not a fit

People with primarily uric acid, cystine, or struvite stones, significant CKD (eGFR <75 mL/min/1.73 m²), extreme urine citrate levels, or who cannot stop diuretics/alkali are unlikely to benefit or be eligible.

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

What this trial studies

At the University of Chicago Clinical Research Center, investigators will enroll two groups of 12 adults each: people with a history of calcium oxalate kidney stones and people without stones and with normal 24‑hour urine oxalate. Participants will receive a single oral dose of potassium citrate and have blood and urine collected over six hours to measure fractional excretion of oxalate and citrate. Changes from baseline will be compared and oxalate fractional excretion will be adjusted for changes in citrate to test a possible transporter-mediated link between the two ions. Key exclusions include non–calcium stone types, significant chronic kidney disease (eGFR <75 mL/min/1.73 m²), extreme urine citrate values, and inability to stop diuretics or alkali supplements.

Why it matters

Potential benefit: If successful, the results could clarify a transporter link between citrate and oxalate and guide better prevention strategies for calcium oxalate kidney stones.

How similar studies have gone: Prior research shows citrate changes urinary chemistry and can reduce stone risk, but the specific transporter-mediated coupling between oxalate and citrate in humans remains largely untested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Stone formers (SF):

* Age 18-70
* History of at least one calcium-based kidney stone

Non-stone formers (NSF):

* Age 18-70
* No history of kidney stone
* 24-hour urine oxalate within laboratory normal range (\<50 mg/day)

Exclusion Criteria:

History of primarily uric acid, cysteine, or struvite stones

History of severe acid-base abnormality, very low (less than 100 mg/day) or very high (greater than 1500 mg/day) urine citrate

Any controls or stone former (SF) participants who cannot stop diuretic medication or alkali supplementation for the course of the study period

Chronic kidney disease (glomerular filtration rate \<75 milliliters per minute per 1.73 square meters \[mL/min/1.73 m²\])

Non-stone formers (NSF) and stone formers (SF) with extreme levels of urine citrate will be excluded from this small initial study to reduce heterogeneity and remove focus from the extremes of citrate levels.

Where it's running

  • University of Chicago Medical Center
    Chicago, Illinois, United States
    Recruiting

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.