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NCT05365477 · ClinicalTrials.gov registry record · Phase 4

Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

A Phase 4 study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
Phase 4
Development phase
56
Enrollment target

NCT05365477: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.

NCT05365477 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05365477, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
56 participants
Enrollment target

Study Summary

The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.

Primary Outcome

Calculated calcium oxalate supersaturation in urine

Interventions

  • BEHAVIORAL Empiric Therapy: Diet
  • DRUG Empiric Therapy: Drug
  • BEHAVIORAL Selective Therapy: Diet
  • DRUG Selective Therapy: Drug

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2022-08-04
Est. Completion 2026-03-31
Phase Phase 4

What the finished NCT05365477 record still lists

NCT05365477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 4 interventions - of which Empiric Therapy: Diet is the first listed.

NCT05365477 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05365477 about?

NCT05365477 is a clinical study titled "Empiric Versus Selective Prevention Strategies for Kidney Stone Disease". The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.

What is the current status of trial NCT05365477?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2022-08-04. Estimated completion is 2026-03-31.

What interventions are being tested in trial NCT05365477?

The interventions under investigation include: Empiric Therapy: Diet (BEHAVIORAL), Empiric Therapy: Drug (DRUG), Selective Therapy: Diet (BEHAVIORAL), Selective Therapy: Drug (DRUG).

Who is sponsoring clinical trial NCT05365477?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05365477's enrollment target sits among peer trials

56 1213th of 2000 higher than 783 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05365477, the US trial registry maintained by the National Library of Medicine. NCT05365477 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.