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

NCT05905926 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: TEN-01-306
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 22

Brief Summary

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

Conditions

Irritable Bowel Syndrome With Constipation (IBS-C)

Outcome Measures

Primary Outcomes (2)

• Safety Measure Assessment (Adverse Event)

  Incidence of AEs, SAEs and drug related adverse events

  40 weeks

• Safety Measure Assessment (ECG)

  Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)

  40 weeks

Study Arms (1)

Tenapanor

EXPERIMENTAL

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

Interventions

Tenapanor DRUG

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

Also known as: Ibsrela

Tenapanor

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≥6 and \<18 years old at enrollment of either parent study
• Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
• 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).
• Subject is ambulatory
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (22)

G & L Research, LLC

Foley, Alabama, 36535, United States

Location

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

Prohealth Research Center

Doral, Florida, 33166, United States

Location

I.H.S. Health, LLC

Kissimmee, Florida, 34741, United States

Location

Valencia Medical and Research Center

Miami, Florida, 33165, United States

Location

Florida Pharmaceutical Research and Associates, Inc.

South Miami, Florida, 33143, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Mankato Clinic/ Javara Research Ltd

Mankato, Minnesota, 56001, United States

Location

Boys Town National Research Hospital

Boys Town, Nebraska, 68010, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Advantage Clinical Trials

The Bronx, New York, 10467, United States

Location

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27705, United States

Location

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States

Location

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

Location

Prisma Health Children's Hospital

Greenville, South Carolina, 29615, United States

Location

Maspons Pediatric Gastro

El Paso, Texas, 79902, United States

Location

Texas Digestive Specialists

Harlingen, Texas, 78550, United States

Location

AIM Trials, LLC

Plano, Texas, 75093, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Pioneer Research Solutions Inc

Sugar Land, Texas, 77479, United States

Location

Frontier Clinical Research

Kingwood, West Virginia, 26537, United States

Location

MeSH Terms

Interventions

tenapanor

Study Officials

• Susan Edelstein, PhD

  Ardelyx

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label study

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: June 15, 2023
• Study Start: February 17, 2023
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (22)