| NCT ID | NCT07225764 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Kidney Stones |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2025-10-23 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Mantu Gupta, MD
PRINCIPAL INVESTIGATOR
Mount Sinai West
Frequently Asked Questions
Who can join the NCT07225764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Stones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07225764 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07225764 currently recruiting?
Yes, NCT07225764 is actively recruiting participants. Contact the research team at blair.gallante@mountsinai.org for enrollment information.
Where is the NCT07225764 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07225764 clinical trial?
NCT07225764 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Mantu Gupta, MD at Mount Sinai West. The trial plans to enroll 80 participants.
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