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NCT03824587 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
A Phase 2 study of Hyperphosphatemia, sponsored by Ardelyx.
- Completed
- Registry status
- Phase 2
- Development phase
- 236
- Enrollment target
- 20
- Study locations
NCT03824587: Completed Phase 2 study of Hyperphosphatemia, sponsored by Ardelyx.
NCT03824587 is a Phase 2 study of Hyperphosphatemia that has completed, run by Ardelyx. The registered enrollment target is 236 participants, below the 830-participant average among 8 other Hyperphosphatemia trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03824587, a Phase 2 study of Hyperphosphatemia, has completed, sponsored by Ardelyx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 236 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.
Primary Outcome
Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tenapanor
- DRUG Phosphate Binder Agents
Study Locations (20)
California
- Southeast Renal Research - Beverly Hills
- California Institute of Renal Research - Chula Vista - Chula Vista
- North America Research Institute - Lynwood
- DaVita Clinical Research - Santa Fe Spring - Montebello
- Central Coast Nephrology - Salinas
- North America Research Institute - San Dimas - San Dimas
- Chabot Nephrology Medical Group - Union City
- American Institute of Research - Whittier
Florida
- Nova Clinical Research, LLC - Bradenton
- Horizon Research Group - Coral Gables - Coral Gables
- South Florida Research Institute - Lauderdale Lakes
- Total Research Group, LLC - Miami
- Omega Research Consultants, LLC - Orlando
- Genesis Clinical Trials - Tampa
Alabama
- Nephrology Consultants, LLC - Huntsville
Arkansas
- US Renal Care Pine Bluff - Pine Bluff
Georgia
- Dialysis Clinic, Inc - Albany GA - Albany
Idaho
- Boise Kidney & Hypertension, PLLC - Meridian - Caldwell
Louisiana
- Renal Associates of Baton Rouge - Baton Rouge
Massachusetts
- Dialysis Clinic, Inc - Boston/Somerville - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2019-02-28 |
| Est. Completion | 2019-07-17 |
| Phase | Phase 2 |
What the finished NCT03824587 record still lists
NCT03824587 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 830-participant average among 8 other Hyperphosphatemia trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Hyperphosphatemia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03824587 names 20 study sites across 8 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT03824587 about?
NCT03824587 is a clinical study titled "Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy". This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.
What is the current status of trial NCT03824587?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 236 participants. The study started on 2019-02-28. Estimated completion is 2019-07-17.
What conditions does trial NCT03824587 study?
This clinical trial studies the following conditions: Hyperphosphatemia.
What interventions are being tested in trial NCT03824587?
The interventions under investigation include: Placebo (DRUG), Tenapanor (DRUG), Phosphate Binder Agents (DRUG).
Who is sponsoring clinical trial NCT03824587?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03824587 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hyperphosphatemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03824587's enrollment target sits among peer trials
236 5th of 8 higher than 4 of 8 other Hyperphosphatemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperphosphatemia 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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