Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

June 2, 2026 updated by: Ardelyx

An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study.

Patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Foley, Alabama, United States, 36535
        • G & L Research, LLC
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc.
    • Florida
      • Doral, Florida, United States, 33166
        • Prohealth Research Center
      • Kissimmee, Florida, United States, 34741
        • I.H.S. Health, LLC
      • Miami, Florida, United States, 33165
        • Valencia Medical and Research Center
      • Orlando, Florida, United States, 32806
        • Orlando Health, Inc.- APH Center for Digestive Health and Nutrition
      • South Miami, Florida, United States, 33143
        • Florida Pharmaceutical Research and Associates, Inc.
    • Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Children's Health
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Health
    • Minnesota
      • Mankato, Minnesota, United States, 56001
        • Mankato Clinic/ Javara Research Ltd
    • Nebraska
      • Boys Town, Nebraska, United States, 68010
        • Boys Town National Research Hospital
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • The Bronx, New York, United States, 10467
        • Advantage Clinical Trials
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health
      • Durham, North Carolina, United States, 27705
        • Duke University School of Medicine
      • Wilmington, North Carolina, United States, 28401
        • Wilmington Health
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Frontier Clinical Research, LLC
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Children's Hospital
    • Texas
      • Abilene, Texas, United States, 79606
        • Advance Clinical Trial PLLC
      • El Paso, Texas, United States, 79902
        • Maspons Pediatric Gastro
      • Harlingen, Texas, United States, 78550
        • Texas Digestive Specialists
      • Plano, Texas, United States, 75093
        • AIM Trials, LLC
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • Sugar Land, Texas, United States, 77479
        • Pioneer Research Solutions Inc
    • West Virginia
      • Kingwood, West Virginia, United States, 26537
        • Frontier Clinical Research

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥6 and <18 years old at enrollment of either parent study
  2. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
  3. Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).
  4. Subject is ambulatory
  5. Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described

Exclusion Criteria:

  1. Patient discontinued prematurely from the parent study.
  2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
  3. Pregnant or lactating women
  4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tenapanor
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per Investigator guidance after a patient's first week on the assigned dose.
Drug: Tenapanor
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID
Other Names:
  • Ibsrela

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Measure Assessment (Adverse Event)
Time Frame: 40 weeks
Incidence of AEs, SAEs and drug related adverse events
40 weeks
Safety Measure Assessment (ECG)
Time Frame: 40 weeks
Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)
40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in alanine aminotransferase (ALT) serum chemistry value (IU/L)
Time Frame: Change from baseline to week 40
To evaluate change from baseline values in tenapanor group versus placebo to assess long term safety
Change from baseline to week 40
Change in aspartate aminotransferase (AST) serum chemistry value (IU/L)
Time Frame: Change from baseline to week 40
To evaluate change from baseline values in tenapanor group versus placebo to assess long term safety
Change from baseline to week 40
Change in serum creatinine value (mg/dL)
Time Frame: Change from baseline to week 40
To evaluate change from baseline values in tenapanor group versus placebo to assess long term safety
Change from baseline to week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardelyx

Investigators

  • Study Director: Jocelyn Tabora, Ardelyx

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 Major Dates

Study Start (Actual)

February 17, 2023

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEN-01-306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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