A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Results posted: Oct 7, 2026
    • Primary endpoint revised
    • Eligibility criteria shortened, about 11 words
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Recruiting to Completed
    • Enrollment target: estimated 25 to confirmed 18
    • Primary and study completion dates changed from estimate of Dec 2025 to Sep 14, 2025
    • Site details revised
    v5
  3. Enrollment target: 10 to 25
    • Primary completion date: Jun 30, 2025 to Dec 2025
    • Study completion date: Aug 31, 2025 to Dec 2025
    • Site contact updated
    v4
  4. Primary completion date: Feb 2025 to Jun 30, 2025
    • Study completion date: Apr 30, 2025 to Aug 31, 2025
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2024 to Jul 1, 2024
    • Site details revised
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This pilot study is proposing a novel approach to directly target intestinal oxalate absorption with the drug Tenapanor, which was recently FDA-approved for treating hyperphosphatemia in patients with chronic kidney disease. Tenapanor works by blocking paracellular phosphate absorption by the intestine, but the underlying mechanisms have not been clearly defined. Since phosphate and oxalate ions are absorbed through the same paracellular pathway, and are of similar size and charge, Tenapanor is hypothesized to also reduce dietary oxalate absorption and consequently lower urinary oxalate excretion.
Trial Details
NCT Number NCT06481150
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)		 Hyperoxaluria
Related terms Hyperoxaluria
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov