A Long-Term 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

• Status: Active, not recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardelyx
• Treatments: Sevelamer

Criteria

Inclusion Criteria:

• Must complete TEN-02-301 (PHREEDOM)

Exclusion Criteria:

1. Schedlued for kidney transplant

2. Life expectancy <12 months