Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Ardelyx

Stay on Your Current Meds

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.

Research Team

David P Rosenbaum, PhD

Principal Investigator

Ardelyx

Eligibility Criteria

Inclusion Criteria

Signed and dated informed consent prior to any study specific procedures.

Males or females aged 18 to 80 years, inclusive, at Screening

Females must be non-pregnant, non-lactating and either be post-menopausal for at least -2 months, have documentation of irreversible surgical sterilization, use of acceptable -contraceptive method, or sexual abstinence, or a sterile sexual partner from Screening -until 30 days after the last subject visit.

Treatment Details

Interventions

• Phosphate Binder Agents (Phosphate Binder Agent)
• Placebo (Placebo)
• Tenapanor (Other)

Participant Groups

Group I: Tenapanor 30 mg BID Experimental Treatment 2 Interventions

During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time). Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.

Group II: Placebo Placebo Group 2 Interventions

same size, weight and appearance of experimental drug

Who Is Running the Clinical Trial?

Ardelyx

Lead Sponsor

Trials

31

Recruited

6,100+