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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 is a Phase 4 study that has completed, run by Ardelyx. The registered enrollment target is 333 participants.
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.
Interventions
- DRUG Tenapanor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2021-12-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04549597
The ClinicalTrials.gov registry entry for NCT04549597 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ardelyx, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tenapanor is the first listed.
NCT04549597 reports 0 study locations.
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.
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