At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 172 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.
A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)
In Brief
A Phase 4 clinical trial evaluating Tenapanor and Sevelamer Carbonate for Hyperphosphatemia and End Stage Renal Disease. Completed, enrolled 172 participants across 1 site.
Detailed Summary
The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP \>2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis with hyperphosphatemia (\>4.5 mg/dL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperphosphatemia, End Stage Renal Disease
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
Enrollment StartJun 2019
First PostedJun 2019
Primary CompletionJun 2021
Study CompletionJul 2021
TodayJul 2026
First PostedJun 18, 2019
Enrollment StartJun 15, 2019
Primary CompletionJun 26, 2021
Study CompletionJul 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.0 years ago
Interventions
Tenapanordrug
NHE3 Inhibitor
Sevelamer Carbonatedrug
Phosphate binder