At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,559 enrolled
Drug / intervention
Tenapanor +2 moredrug
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.
A 26-Wk, Phase 3, Open Label (OL) Study With a 12-Wk, Placebo-Controlled, Randomized Withdrawal Period and an OL Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in CKD Patients on Dialysis
In Brief
A Phase 3 clinical trial evaluating Tenapanor, Placebo, and 1 other intervention for Hyperphosphatemia. Completed, enrolled 1,559 participants across 2 sites.
Detailed Summary
This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperphosphatemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedFeb 2018
Primary CompletionNov 2019
Study CompletionFeb 2020
TodayJul 2026
First PostedFeb 9, 2018
Enrollment StartJan 8, 2018
Primary CompletionNov 15, 2019
Study CompletionFeb 27, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.4 years ago
Interventions
Tenapanordrug
Active Drug
Placebodrug
Inactive Drug
Sevelamer Carbonatedrug
Active control