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

End Stage Renal Disease Clinical Trial

— NORMALIZE  

Official title:

A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988920
• Other study ID #: TEN-02-401
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2023
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: July 31, 2021
• Est. primary completion date: June 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Must complete TEN-02-301 (PHREEDOM)

Exclusion Criteria:

1. Schedlued for kidney transplant

2. Life expectancy <12 months

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hyperphosphatemia
• Kidney Failure, Chronic

Intervention

Drug:
• Tenapanor
NHE3 Inhibitor
• Sevelamer Carbonate
Phosphate binder

Locations

Country	Name	City	State
United States	Ardelyx Site #509	Houston	California

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieving Normal Serum Phosphorus Level	Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL	18 months
Secondary	Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline	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	up to 2.5 years
Secondary	Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit	Baseline upon enrollment in the 18-month long-term extension study	up to 18 months