At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 219 enrolled
Drug / intervention
Tenapanor +1 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.
An 8-week, Multicenter, Randomized, Double-Blind, Parallel Group Study With a 4-week, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Efficacy, Safety, and Tolerability of Tenapanor to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
In Brief
A Phase 3 clinical trial evaluating Tenapanor and Placebo for Hyperphosphatemia. Completed, enrolled 219 participants across 32 sites.
Detailed Summary
This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a 4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperphosphatemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJan 2016
First PostedFeb 2016
Primary CompletionDec 2016
Study CompletionJan 2018
TodayJul 2026
First PostedFeb 5, 2016
Enrollment StartJan 1, 2016
Primary CompletionDec 1, 2016
Study CompletionJan 17, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.4 years ago
Interventions
Tenapanordrug
Placebodrug