NCT03988920

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperphosphatemia
• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Tenapanor	NHE3 Inhibitor
DRUG	Sevelamer Carbonate	Phosphate binder

Timeline

• Start date: 2019-06-15
• Primary completion: 2021-06-26
• Completion: 2021-07-31
• First posted: 2019-06-18
• Last updated: 2023-03-29
• Results posted: 2023-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study