At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 236 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 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosphatemia
In Brief
A Phase 3 clinical trial evaluating Tenapanor, Placebo, and 1 other intervention for Hyperphosphatemia. Completed, enrolled 236 participants across 48 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperphosphatemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartFeb 2019
Primary CompletionJul 2019
TodayJul 2026
First PostedJan 31, 2019
Enrollment StartFeb 28, 2019
Primary CompletionJul 17, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.4 years ago
Interventions
Tenapanordrug
Active Drug
Placebodrug
Inactive Drug
Phosphate Binder Agentsdrug
standard of care phosphate binder use at study entry was maintained throughout the entire study