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Kidney Stone Prevention Study

This study is for adults with calcium oxalate kidney stones who are having surgery (PCNL) to remove them. It's testing two ways to prevent new stones: one uses the medication Chlorthalidone (25 mg daily) and a low oxalate diet based on your stone type, and the other uses these same treatments but adjusted based on your 24-hour urine test results. The study wants to see if the simpler approach (based on stone type) works as well as the more detailed one. We'll measure changes in calcium oxalate supersaturation (a measure of how likely you are to form stones) after 4-6 weeks to see which approach is more effective. You can join if you are at least 18 years old, have calcium oxalate kidney stones, are scheduled for PCNL, and have good kidney function (eGFR greater than 70 mL/min/1).

Study design
This is a single-center randomized controlled trial at Mount Sinai West, planning to enroll 80 participants. You will be randomly assigned to one of two treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your calcium oxalate supersaturation will be measured at 4-6 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07225764

CaOx Stone Prevention

Recruiting
PHASE4Ages 18+InterventionalPrevention
Icahn School of Medicine at Mount Sinai
~80 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:ChlorthalidoneLow oxalate diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in super saturation of calcium oxalate
Measured over 4-6 weeks

Conditions

Kidney Stones

Explore related trials

Nephrolithiasis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Mantu Gupta, MD · PRINCIPAL_INVESTIGATOR · Mount Sinai West

Who to contact

Blair Gallante, MPH
[email protected]
631-991-1159
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult age of 18 years
Diagnosed with kidney stones and scheduled for PCNL.
Calcium Oxalate Stone Former
Pre-operative CT-scan within 90 days of surgery and stone density with \> 1000 Hounsfield units
Non-pregnant or breastfeeding
Able and willing to provide informed consent.
Pre-operative eGFR greater than 70 mL/min/1.73 m² -Negative pre-operative urine culture

Exclusion

Documented history of gastric or intestinal bypass, liver disease, history of gastrointestinal malabsorptive disease (Crohn's disease, ulcerative colitis, and short-gut syndrome)
Hyperparathyroidism -Renal tubular acidosis
Active kidney stone prevention treatment (use of thiazides, alkaline therapy, or low oxalate diet) at the time of surgery
History of hypokalemia or baseline hypotension
Allergy to medications used in trial or sulfa-containing medications
Patient prescribed thiazide, loop diuretics, carbonic anhydrase inhibitors, xanthine oxidase inhibitors, active Vitamin D, bisphosphonates, denosumab, glucocorticoids, or potassium supplementation

What this trial measures

  • Changes in super saturation of calcium oxalate4-6 weeks

    Change in urine calcium oxalate supersaturation from baseline to the final follow-up visit, measured via 24-hour urine collection. This is a marker that can be predictive of stone episodes, as recurrent stones may take years to develop.