CaOx Stone Prevention

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07225764
Phase
PHASE4
Status
Recruiting
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Conditions

  • Kidney Stones

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chlorthalidone — DRUG
    Chlorthalidone 25 mg orally once daily is used to reduce urinary calcium excretion and prevent recurrent calcium-containing kidney stones. In this study, it is prescribed either based on stone composition (empiric group) or guided by 24-hour urine results (selective group) for participants meeting criteria for hypercalciuria or calcium oxalate dihydrate stones.
  • Low oxalate diet — BEHAVIORAL
    Participants receive counseling to follow a low oxalate diet, limiting high oxalate foods (\>50 mg/100 g) and restricting moderate oxalate foods (\<50 mg/100 g) to a single four-ounce serving per day. The diet is prescribed either based on stone composition (empiric group) or guided by 24-hour urine results (selective group) for participants with idiopathic hyperoxaluria or calcium oxalate monohydrate stones.

Study Details

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.

Key Dates

Start date
Oct 23, 2025
Status verified
Nov 2025
Primary completion
Jun 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Empiric Therapy
    Patients randomized to the empiric group will receive treatment based on the pH on urinalysis and stone composition. Patients with greater than 50% calcium oxalate monohydrate (COM) stone composition will be counseled on a low oxalate diet by a medical provider. Patients with greater than 50% calcium oxalate dihydrate (COD) stone composition will be prescribed 25 mg of chlorthalidone once a day. In the rare event the stone composition is 50% COM and 50% COD, then those patients will receive both low oxalate diet counseling and a prescription for chlorthalidone.
  • Active Comparator: Selective Therapy
    Patients randomized to the selective group will undergo medical therapy based on the American Urological Association (AUA) guidelines from the 24-hour urine collection results. Patients with idiopathic hyperoxaluria (\> 40mg/day) will receive a low oxalate diet and receive the same dietary counseling, handout, and questionnaire as the empiric group. Patients with idiopathic hypercalciuria (\> 250mg in men, \>200mg in women) will be prescribed 25mg of chlorthalidone once a day.

Primary Outcome Measure

Changes in super saturation of calcium oxalate [ Time Frame: 4-6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai WestNew YorkNew York10019
Mantu Gupta, MD
[email protected]
212-241-1272
Blair Gallante, MPH
[email protected]
631-991-1159
Mantu Gupta (PRINCIPAL_INVESTIGATOR)

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