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Recruiting NCT07225764

CaOx Stone Prevention

Phase IV Interventional Kidney Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chlorthalidone, Low oxalate diet.
Who it may be relevant to
Registry conditions: Kidney Stones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

This is a single-center, randomized controlled trial evaluating the effectiveness of empiric versus selective medical therapy for the prevention of calcium oxalate kidney stones. The study will enroll 80 patients at Mount Sinai West undergoing percutaneous nephrolithotomy (PCNL) for predominantly calcium oxalate stones. Participants will be randomized postoperatively to receive either empiric therapy (based on stone composition and urinalysis) or selective therapy (based on 24-hour urine metabolic evaluation). The primary endpoint is the change in calcium oxalate supersaturation (ssCaOx) at 4 weeks post-treatment. The study is designed to determine whether an empiric approach can achieve comparable outcomes to selective therapy while simplifying access to preventive treatment.

Interventions

  • Drug Chlorthalidone
    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.
  • Behavioral Low oxalate diet
    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.

Primary outcome measures

  • Changes in super saturation of calcium oxalate [Time frame: 4-6 weeks]
Secondary outcome measures (3)
  • Changes in urinary oxalate levels [Time frame: 4-6 weeks]
  • Changes in urinary calcium levels [Time frame: 4-6 weeks]
  • Chlorthalidone Adherence Survey (adapted from Brief Medication Questionnaire) [Time frame: 4-6 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Mount Sinai West — New York

Identifiers

NCT: NCT07225764 · STUDY-25-00784

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗