Actively Recruiting
CaOx Stone Prevention
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-11-10
80
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CaOx Stone Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with stone density > 1000 Hounsfield units
- Non-pregnant and not breastfeeding
- Able and willing to provide informed consent
- Pre-operative eGFR greater than 70 mL/min/1.73 m8
- Negative pre-operative urine culture
You will not qualify if you...
- History of gastric or intestinal bypass, liver disease, or gastrointestinal malabsorptive diseases such as Crohn's disease, ulcerative colitis, or short-gut syndrome
- Hyperparathyroidism
- Renal tubular acidosis
- Active kidney stone prevention treatment at time of surgery (thiazides, alkaline therapy, low oxalate diet)
- History of hypokalemia or baseline hypotension
- Allergy to trial medications or sulfa-containing medications
- Current prescription of thiazide, loop diuretics, carbonic anhydrase inhibitors, xanthine oxidase inhibitors, active Vitamin D, bisphosphonates, denosumab, glucocorticoids, or potassium supplementation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
Research Team
B
Blair Gallante, MPH
CONTACT
M
Mantu Gupta, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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