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NCT03427125 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
A Phase 3 study, sponsored by Ardelyx.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,559
- Enrollment target
NCT03427125: Completed Phase 3 study, sponsored by Ardelyx.
NCT03427125 is a Phase 3 study that has completed, run by Ardelyx. The registered enrollment target is 1,559 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03427125, a Phase 3 study, has completed, sponsored by Ardelyx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,559 participants
- Enrollment target
Study Summary
This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal dialysis.
Primary Outcome
Patients with at least a 1.2 mg/dL decrease in serum phosphorus during the first 26 weeks of the study were defined as the responder population.
Interventions
- DRUG Placebo
- DRUG Tenapanor
- DRUG Sevelamer Carbonate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,559 participants |
| Start Date | 2018-01-08 |
| Est. Completion | 2020-02-27 |
| Phase | Phase 3 |
What the finished NCT03427125 record still lists
NCT03427125 is an interventional study that assigns participants to a tested intervention. Its 1,559 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03427125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03427125 about?
NCT03427125 is a clinical study titled "A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis". This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal...
What is the current status of trial NCT03427125?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,559 participants. The study started on 2018-01-08. Estimated completion is 2020-02-27.
What interventions are being tested in trial NCT03427125?
The interventions under investigation include: Placebo (DRUG), Tenapanor (DRUG), Sevelamer Carbonate (DRUG).
Who is sponsoring clinical trial NCT03427125?
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 NCT03427125's enrollment target sits among peer trials
1,559 150th of 2000 higher than 1,851 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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