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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Mount Sinai West
RECRUITING
New York
Contact Information
Primary
Blair Gallante, MPH
blair.gallante@mountsinai.org
631-991-1159
Backup
Mantu Gupta, MD
mantu.gupta@mountsinai.org
212-241-1272
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov

Similar Clinical Trials