NCT03427125

A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

A 26-Wk, Phase 3, Open Label (OL) Study With a 12-Wk, Placebo-Controlled, Randomized Withdrawal Period and an OL Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in CKD Patients on Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,559 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal dialysis.

Detailed description

The study consists of a screening visit, a phosphate binder-free washout period of up to 4 weeks, a 26-week treatment period, an up to 12-week placebo-controlled, randomized withdrawal period, during which patients are randomized 1:1 to either remain on their tenapanor treatment or placebo, followed by an open label safety extension period for a total treatment period of up to 52 weeks. An active control group, for safety analysis only, will receive sevelamer carbonate, open label, for the entire 52-week study period Depending on increase in serum phosphate (s-P) levels, subjects can be randomized 2 or 3 weeks after being taken off their phosphate lowering medication. Subjects who qualify to enroll in the study will be randomized 3:1 to either receive tenapanor at a dose of 30 mg bid or sevelamer carbonate.

Conditions

• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	Tenapanor	Active Drug
DRUG	Placebo	Inactive Drug
DRUG	Sevelamer Carbonate	Active control

Timeline

• Start date: 2018-01-08
• Primary completion: 2019-11-15
• Completion: 2020-02-27
• First posted: 2018-02-09
• Last updated: 2023-06-29
• Results posted: 2023-06-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study