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Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

StatusRecruiting
PhasePhase 4
Started2023-12-13
View on ClinicalTrials.gov ↗

Amendment history

2026-06-01
2 amendments v4-v5
2 re-verifications since 2025-04-02, no change to tracked fields
2024-04-11
Study Status v3
Start date2023-10-11→2023-12-13
2023-10-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-09-01→confirmed 2023-10-11
Study sites0→1
2023-08-25
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Eligibility criteria+53 characters
Inclusion Criteria: - CaPCalcium 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
Secondary endpointsdetails revised at 2 of 2 entries
Primary endpoints1 entry, revised
Formation product (FP) for Calcium Phosphate
Study description+70 characters
[...] blocked randomization scheme. The 4 phases will be Placebo, Super CitriMax (hydroxycitrate) OHCit low dose, OHCit standard dose, or Potassium Citrate. Randomization will be stratified based on sex, conc [...] ly during each phase. These will consist of either placebo, Potassium Citrate (KCit), or Super CitriMax (OHCit). Study tablets will be prepared by a compounding pharmacy, [...]
2023-08-14
Original filing
This study tests whether hydroxycitrate, a molecule closely related to citrate, can reduce calcium phosphate stone recurrence.
Trial Details
NCT Number NCT06003348
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Calcium Phosphate Kidney Stones
Enrollment 25 participants
Start Date 2023-12-13
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-02