COMPLETED

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Quick Facts

Study Start:2024-07-01
Study Completion:2025-09-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06481150

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Normal, healthy adult volunteers
  1. * Personal history of kidney stones
  2. * Pregnant or nursing
  3. * Recurrent urinary tract infections
  4. * Lithogenic urine chemistry at baseline (oxalate \> 45 mg/24 h, urine calcium \> 300 mg/24 h)
  5. * Chronic kidney disease (eGFR \< 90 mL/min/1.73m2)
  6. * Personal history of GI disease, GI obstruction, or GI surgery
  7. * Chronic diarrhea
  8. * Intestinal inflammation (Fecal calprotectin \> 120 mcg/g)
  9. * Drugs which are substrates of OATP2B1 (e.g. enalapril)
  10. * Chronic use of sodium polystyrene sulfonate, angiotensin-converting enzyme inhibitors, diuretics, antacids, alkali treatment, or carbonic anhydrase inhibitors.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2025-09-14

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2025-09-14

Terms related to this study

Additional Relevant MeSH Terms

  • Hyperoxaluria