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CaOx Stone Prevention
Empiric vs Selective Medical Therapy for Calcium Oxalate Stone Prevention: A Randomized Controlled Trial
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
This single-center randomized controlled trial at Mount Sinai West will enroll 80 patients undergoing percutaneous nephrolithotomy for calcium oxalate stones. Participants will be randomized to receive either empiric therapy or selective therapy guided by 24-hour urine evaluation. The primary outcome is change in calcium oxalate supersaturation at 4 weeks, aiming to determine whether empiric therapy can provide outcomes comparable to selective therapy while simplifying access to prevention.
What is being tested
- Chlorthalidone (drug)
- Low oxalate diet (behavioral)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 80 · Started: Oct 23, 2025
Contact the study team
- Blair Gallante, MPH · Phone: 631-991-1159
- Mantu Gupta, MD · Phone: 212-241-1272
Official record on ClinicalTrials.gov — NCT07225764
Locations in the U.S.
| New York | Mount Sinai West, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.