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Can a One-Size-Fits-All pill beat kidney stones?

NCT ID NCT07225764

Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study is testing whether a simple, standard prevention plan works as well as a personalized one for people who get calcium oxalate kidney stones. 80 participants will either receive a diuretic and diet advice based on their stone type alone, or have their treatment guided by detailed urine tests. The goal is to see if the simpler approach can lower the risk of future stones without the need for complex testing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Chlorthalidone (a diuretic) and a low oxalate diet
What this could lead to
If successful, this could show that a simpler, cheaper prevention plan works just as well as a more complex, personalized one, making stone prevention more accessible.
What could go wrong
This is a small, early-phase trial (80 people) looking at a lab marker, not actual stone recurrence. The simpler approach may not be as effective for everyone, and the drug has potential side effects like low potassium or dizziness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis nephrolithiasis, calcium oxalate

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney stones

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

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