A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06481150
Phase
PHASE4
Status
Completed

Conditions

  • Hyperoxaluria

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Tenapanor — DRUG
    Each tablet 30 mg
  • Placebo — OTHER
    Placebo

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Feb 2026
Primary completion
Sep 14, 2025
Completion
Sep 14, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Tenapanor
    30 mg Tenapanor twice a day
  • Placebo Comparator: Placebo
    30 mg Placebo twice a day

Primary Outcome Measure

24-h urine oxalate [ Time Frame: Two 24-h urine on days 4 and 5 of each arm ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390-

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By research site
UT Southwestern Medical Center· Dallas, TX

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