CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 333 enrolled
Drug / intervention
Tenapanordrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04549597
NCT04549597Phase 4Completed

Randomized Open-Label Study to Evaluate Tenapanor as the Core Therapy in the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Who Are Phosphate Binder Naive or on Phosphate Binders to Optimize Phosphorus Management

Ardelyx·interventional·Posted Sep 16, 2020·Updated Mar 29, 2023

In Brief

A Phase 4 clinical trial evaluating Tenapanor for Chronic Kidney Disease Requiring Chronic Dialysis and Hyperphosphatemia. Completed, enrolled 333 participants across 1 site.

Detailed Summary

This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy. The objective to evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy (alone or in combination with phosphate binders) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedSep 16, 2020
Enrollment StartNov 20, 2020
Primary CompletionOct 13, 2021
Study CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.8 years ago

Interventions

Tenapanordrug

Use of tenapanor