A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Description

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.

Conditions

Hyperoxaluria

Study Overview

Study Details

Study overview

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.

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Condition
Hyperoxaluria
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Normal, healthy adult volunteers
  • * 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Jonathan M Whittamore, Ph.D., PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

2025-04-30