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NCT06003348 · ClinicalTrials.gov registry record · Phase 4

Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

A Phase 4 study of Calcium Phosphate Kidney Stones, sponsored by University of Texas Southwestern Medical Center.

Recruiting
Registry status
Phase 4
Development phase
25
Enrollment target
1
Study location

NCT06003348: Recruiting Phase 4 study of Calcium Phosphate Kidney Stones, sponsored by University of Texas Southwestern Medical Center.

NCT06003348 is a Phase 4 study of Calcium Phosphate Kidney Stones that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06003348, a Phase 4 study of Calcium Phosphate Kidney Stones, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.

RECRUITING
Registry status
Phase 4
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

This study tests whether hydroxycitrate, a molecule closely related to citrate, can reduce calcium phosphate stone recurrence.

Primary Outcome

FP is obtained by adding increasing amounts of Calcium Chloride (CaCl2) to a series of urine aliquots maintained at constant pH for 2 hours, and is identified by the point at which calcium phosphate (CaP) precipitates as detected by an absorbance microplate reader. Calculated supersaturation using \[Calcium\] and \[Phosphate\] at that point represents FP.

Interventions

  • DRUG Placebo
  • DIETARY_SUPPLEMENT OHCit- standard dose
  • DRUG Potassium Citrate
  • DIETARY_SUPPLEMENT OHCit- low dose

Study Locations (1)

Texas

  • UT Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2023-12-13
Est. Completion 2028-08-31
Phase Phase 4

What NCT06003348 shows while recruiting

NCT06003348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Calcium Phosphate Kidney Stones appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT06003348 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06003348 about?

NCT06003348 is a clinical study titled "Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones". This study tests whether hydroxycitrate, a molecule closely related to citrate, can reduce calcium phosphate stone recurrence.

What is the current status of trial NCT06003348?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2023-12-13. Estimated completion is 2028-08-31.

What conditions does trial NCT06003348 study?

This clinical trial studies the following conditions: Calcium Phosphate Kidney Stones.

What interventions are being tested in trial NCT06003348?

The interventions under investigation include: Placebo (DRUG), OHCit- standard dose (DIETARY_SUPPLEMENT), Potassium Citrate (DRUG), OHCit- low dose (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT06003348?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06003348 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06003348's enrollment target sits among peer trials

25 1669th of 2000 higher than 303 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 NCT06003348, the US trial registry maintained by the National Library of Medicine. NCT06003348 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.