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NCT04549597 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
A Phase 4 study, sponsored by Ardelyx.
- Completed
- Registry status
- Phase 4
- Development phase
- 333
- Enrollment target
NCT04549597: Completed Phase 4 study, sponsored by Ardelyx.
NCT04549597 is a Phase 4 study that has completed, run by Ardelyx. The registered enrollment target is 333 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04549597, a Phase 4 study, has completed, sponsored by Ardelyx.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 333 participants
- Enrollment target
Study 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.
Primary Outcome
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 for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
Interventions
- DRUG Tenapanor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2021-12-01 |
| Phase | Phase 4 |
What the finished NCT04549597 record still lists
NCT04549597 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 1 intervention - of which Tenapanor is the first listed.
NCT04549597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04549597 about?
NCT04549597 is a clinical study titled "Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia". 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 combinati...
What is the current status of trial NCT04549597?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 333 participants. The study started on 2020-11-20. Estimated completion is 2021-12-01.
What interventions are being tested in trial NCT04549597?
The interventions under investigation include: Tenapanor (DRUG).
Who is sponsoring clinical trial NCT04549597?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04549597's enrollment target sits among peer trials
333 252nd of 2000 higher than 1,748 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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