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

Phase 3

• Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
• Interventions: Drug: Tenapanor

• Registration Number: NCT05905926
• Lead Sponsor: Ardelyx

Brief Summary

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

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 Timeline

• Study Start: 2023-02-17
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2031-07
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tenapanor	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by MedDRA v26.0	40 weeks	To evaluate the difference in % adverse events between Placebo and Tenapanor to assess the long term safety

Secondary Outcome Measures

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

Trial Locations

Locations (17)

Advantage Clinical Trials; 🇺🇸 Bronx, New York, United States

Frontier Clinical Research; 🇺🇸 Kingwood, West Virginia, United States

G & L Research, LLC; 🇺🇸 Foley, Alabama, United States

Advanced Research Center, Inc.; 🇺🇸 Anaheim, California, United States

Prohealth Research Center; 🇺🇸 Doral, Florida, United States

I.H.S. Health, LLC; 🇺🇸 Kissimmee, Florida, United States

Valencia Medical and Research Center; 🇺🇸 Miami, Florida, United States

Florida Pharmaceutical Research and Associates, Inc.; 🇺🇸 South Miami, Florida, United States

Boys Town National Research Hospital; 🇺🇸 Boys Town, Nebraska, United States

SUNY Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Frontier Clinical Research, LLC; 🇺🇸 Smithfield, Pennsylvania, United States

Prisma Health Children's Hospital; 🇺🇸 Greenville, South Carolina, United States

Texas Digestive Specialists; 🇺🇸 Harlingen, Texas, United States

AIM Trials, LLC; 🇺🇸 Plano, Texas, United States

Sun Research Institute; 🇺🇸 San Antonio, Texas, United States

Pioneer Research Solutions Inc; 🇺🇸 Sugar Land, Texas, United States