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NCT02675998 · ClinicalTrials.gov registry record · Phase 3
An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
A Phase 3 study, sponsored by Ardelyx.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
NCT02675998 is a Phase 3 study that has completed, run by Ardelyx. The registered enrollment target is 219 participants.
The verdict
NCT02675998, a Phase 3 study, has completed, sponsored by Ardelyx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Tenapanor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-01-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02675998
The ClinicalTrials.gov registry entry for NCT02675998 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 219 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 2 interventions - of which Placebo is the first listed.
NCT02675998 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02675998 about?
NCT02675998 is a clinical study titled "An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)". 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)...
What is the current status of trial NCT02675998?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2016-01. Estimated completion is 2018-01-17.
What interventions are being tested in trial NCT02675998?
The interventions under investigation include: Placebo (DRUG), Tenapanor (DRUG).
Who is sponsoring clinical trial NCT02675998?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
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