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Recruiting Phase 4 NCT06003348

NCT06003348 Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

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Clinical Trial Summary
NCT ID NCT06003348
Status Recruiting
Phase Phase 4
Sponsor University of Texas Southwestern Medical Center
Condition Calcium Phosphate Kidney Stones
Study Type INTERVENTIONAL
Enrollment 25 participants
Start Date 2023-12-13
Primary Completion 2028-05-31

Eligibility & Interventions

Sex All sexes
Min Age 21 Years
Max Age 99 Years
Study Type INTERVENTIONAL
Interventions
OHCit- standard dosePotassium CitratePlacebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 25 participants in total. It began in 2023-12-13 with a primary completion date of 2028-05-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: \- Calcium Phosphate stone formers Exclusion Criteria: * History of recurrent urinary tract infections * Chronic diarrhea * Estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73 m2 * History of primary hyperparathyroidism * Hypokalemia * Hyperkalemia * Pregnancy

Contact & Investigator

Central Contact

NAIM M MAALOUF, MD

✉ naim.maalouf@utsouthwestern.edu

📞 214/648-2954

Principal Investigator

NAIM M MAALOUF

PRINCIPAL INVESTIGATOR

University of Texas Southwestern Medical Center

Frequently Asked Questions

Who can join the NCT06003348 clinical trial?

This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Calcium Phosphate Kidney Stones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06003348 trial and what does that mean for participants?

Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.

Is NCT06003348 currently recruiting?

Yes, NCT06003348 is actively recruiting participants. Contact the research team at naim.maalouf@utsouthwestern.edu for enrollment information.

Where is the NCT06003348 trial being conducted?

This trial is being conducted at Dallas, United States.

Who is sponsoring the NCT06003348 clinical trial?

NCT06003348 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is NAIM M MAALOUF at University of Texas Southwestern Medical Center. The trial plans to enroll 25 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: September 2026  ·  Data Methodology