Recruiting PHASE4 Kidney Stones

Prevention study for Kidney Stones

Official title CaOx Stone Prevention

ClinicalTrials.gov ID: NCT07225764

What this study is testing

What is Chlorthalidone?

Chlorthalidone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for kidney stones.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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

You likely can't join if

  • Documented history of gastric or intestinal bypass, liver disease, history of gastrointestinal malabsorptive disease (Crohn's disease, ulcerative...
  • 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...
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • New York, New York, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.