A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Completed · Phase 4 · Has a placebo group

Conditions studied: Hyperoxaluria

In brief

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 facts

Study ID

NCT06481150

Run by

University of Texas Southwestern Medical Center

People needed

18

Starts

2024-07-01

Expected to finish

2025-09-14

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal, healthy adult volunteers

You may not qualify if…

• Personal history of kidney stones
• Pregnant or nursing
• Recurrent urinary tract infections
• Lithogenic urine chemistry at baseline (oxalate > 45 mg/24 h, urine calcium > 300 mg/24 h)
• Chronic kidney disease (eGFR < 90 mL/min/1.73m2)
• Personal history of GI disease, GI obstruction, or GI surgery
• Chronic diarrhea
• Intestinal inflammation (Fecal calprotectin > 120 mcg/g)
• Drugs which are substrates of OATP2B1 (e.g. enalapril)
• Chronic use of sodium polystyrene sulfonate, angiotensin-converting enzyme inhibitors, diuretics, antacids, alkali treatment, or carbonic anhydrase inhibitors.

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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