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

NCT03824587 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2023-03-06

Study results available
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Summary

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.

Conditions

  • Hyperphosphatemia

Interventions

DRUG

Tenapanor

Active Drug

DRUG

Placebo

Inactive Drug

DRUG

Phosphate Binder Agents

standard of care phosphate binder use at study entry was maintained throughout the entire study

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • David P Rosenbaum, PhD · Ardelyx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2019-07-17
Completion
2019-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824587 on ClinicalTrials.gov