A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP

Phase 4

Completed

• Conditions: Hyperphosphatemia; End Stage Renal Disease
• Interventions: Drug: Tenapanor; Drug: Sevelamer Carbonate

• Registration Number: NCT03988920
• Lead Sponsor: Ardelyx

Brief Summary

The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP \>2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis with hyperphosphatemia (\>4.5 mg/dL).

Detailed Description

Patients who complete the TEN-02-301 study (PHREEDOM) may be eligible to enroll into TEN-02-401 (NORMALIZE).

Patients from the TEN-02-301 tenapanor arm will either receive only tenapanor or be given sevelamer in addition to tenapanor based on their sP. Patients from the TEN-02-301 sevelamer arm will be given tenapanor in addition to their sevelamer dose and the sevelamer dose will then be adjusted based on their sP following a protocol-specified dose titration schedule. Patients will be monitored for safety and efficacy with in-office and telephone visits for up to an additional 18 months.

Laboratory assessments will be measured at every visit (Weeks 1, 2, 3, 4, 6 and 8 and Months 3, 6, 9, 12, 15 and 18) using a central laboratory.

Safety assessments will be performed during the study and will include physical examinations, vital signs (blood pressure and pulse), body weights, clinical laboratory evaluations, 12-lead electrocardiograms (ECGs), and adverse event (AE) monitoring.

Study Timeline

• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-14
• Study Start: 2019-06-15
• Study First Posted: 2019-06-18
• Primary Completion: 2021-06-26
• Study Completion: 2021-07-31
• Status Verified: 2023-03
• Results First Submitted: 2023-03-03
• Results First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Results First Posted: 2023-03-29
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Must complete TEN-02-301 (PHREEDOM)

Exclusion Criteria

1. Schedlued for kidney transplant
2. Life expectancy <12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenapanor w/Sevelamer	Tenapanor	Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Tenapanor w/Sevelamer	Sevelamer Carbonate	Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Sevelamer w/Tenapanor	Sevelamer Carbonate	Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed
Sevelamer w/Tenapanor	Tenapanor	Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed

Primary Outcome Measures

Name	Time	Method
Achieving Normal Serum Phosphorus Level	18 months	Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL

Secondary Outcome Measures

Name	Time	Method
Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline	up to 2.5 years	The change from the baseline s-P from the parent study until the endpoint visit which was up to 2.5 years after the baseline
Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit	up to 18 months	Baseline upon enrollment in the 18-month long-term extension study

Trial Locations

Locations (1)

Ardelyx Site #509; 🇺🇸 Houston, California, United States