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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Preventing calcium oxalate kidney stones

Official title: Empiric vs Selective Medical Therapy for Calcium Oxalate Stone Prevention: A Randomized Controlled Trial

Run by Icahn School of Medicine at Mount Sinai · NCT07225764 · Data updated 2026-11-12

This test compares giving empiric preventive treatment right after kidney stone surgery to using 24-hour urine tests to guide treatment for people with calcium oxalate stones.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Drugs / interventionsdenosumab
Locations1 site (New York, New York)
StatusRecruiting
StartedOctober 23, 2025
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedAugust 14, 2026
Trial IDNCT07225764 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) scheduled for PCNL for predominantly calcium oxalate stones with preoperative eGFR >70 mL/min/1.73 m², a negative urine culture, and not currently on active stone prevention therapy are ideal candidates.

Probably not a fit

Patients with non–calcium oxalate stones, gastrointestinal malabsorption or prior bypass surgery, hyperparathyroidism or renal tubular acidosis, reduced kidney function, current use of thiazides or other stone prevention meds, or allergies to the study drugs are unlikely to benefit.

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

What this trial studies

This single-center randomized controlled trial at Mount Sinai West will enroll 80 adults undergoing percutaneous nephrolithotomy for predominantly calcium oxalate stones. After surgery participants are randomized to empiric therapy (based on stone composition and urinalysis, including chlorthalidone and a low-oxalate diet) or selective therapy guided by a 24-hour urine metabolic evaluation. The primary endpoint is the change in calcium oxalate supersaturation at four weeks. The study is designed to see whether an empiric approach can achieve comparable short-term biochemical outcomes while simplifying access to preventive treatment.

Why it matters

Potential benefit: If successful, empiric treatment could simplify and speed access to stone prevention without waiting for 24-hour urine results, potentially lowering recurrent stone risk.

How similar studies have gone: Thiazide diuretics and low-oxalate diets individually have evidence to reduce calcium oxalate recurrence, but directly comparing empiric versus 24-hour urine–guided selective therapy is relatively novel and not well established.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Mount Sinai West
    New York, New York, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
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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.