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

Conditions

• Hyperphosphatemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Tenapanor — DRUG
  Active Drug
• Placebo — DRUG
  Inactive Drug
• Phosphate Binder Agents — DRUG
  standard of care phosphate binder use at study entry was maintained throughout the entire study

Study Details

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.

Key Dates

Start date

Feb 28, 2019

Status verified

Feb 2023

Primary completion

Jul 17, 2019

Completion

Jul 17, 2019

Study Design

Enrollment

236 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tenapanor 30 mg BID
  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.
• Placebo Comparator: Placebo
  same size, weight and appearance of experimental drug

Primary Outcome Measure

Change in Serum Phosphorus (s-P) Level From Baseline to Week 4. [ Time Frame: 4 Weeks (28 days randomization period; from baseline to week 4) ]

Locations (48)

Find similar trials in Huntsville, AL

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