An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Public ClinicalTrials.gov record NCT02675998. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An 8-week, Multicenter, Randomized, Double-Blind, Parallel Group Study With a 4-week, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Efficacy, Safety, and Tolerability of Tenapanor to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02675998
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 219 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2015
- Primary completion
- Nov 30, 2016
- Completion
- Jan 16, 2018
- Last update posted
- Aug 9, 2020
2016 – 2018
United States locations
- U.S. sites
- 32
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ardelyx Investigative Site 429 | Huntsville | Alabama | 35805 | — |
| Ardelyx Investigative Site 425 | Riverside | California | 92505 | — |
| Ardelyx Clinical Site 403 | Denver | Colorado | 80230 | — |
| Ardelyx Investigative Site 410 | Lauderdale Lakes | Florida | 33313 | — |
| Ardelyx Investigative Site 430 | Miami | Florida | 33173 | — |
| Ardelyx Investigative Site 427 | Meridian | Idaho | 83642 | — |
| Ardelyx Investigative Site 432 | Shreveport | Louisiana | 71101 | — |
| Ardelyx Investigative Site 415 | Bethesda | Maryland | 20814 | — |
| Ardelyx Investigative Site 402 | Kalamazoo | Michigan | 49008 | — |
| Ardelyx Investigative Site 424 | Roseville | Michigan | 48066 | — |
| Ardelyx Investigative Site 409 | Brookhaven | Mississippi | 39601 | — |
| Ardelyx Investigative Site 417 | Columbus | Mississippi | 39705 | — |
| Ardelyx Investigative Site 431 | Tupelo | Mississippi | 38801 | — |
| Ardelyx Investigative Site 423 | St Louis | Missouri | 63136 | — |
| Ardelyx Investigative Site 416 | Albuquerque | New Mexico | 87109 | — |
| Ardelyx Investigative Site 419 | The Bronx | New York | 10803 | — |
| Ardelyx Investigative Site 408 | Asheville | North Carolina | 28805 | — |
| Ardelyx Investigative Site 411 | Charlotte | North Carolina | 28204 | — |
| Ardelyx Investigative Site 420 | New Bern | North Carolina | 28562 | — |
| Ardelyx Investigative Site 426 | Raleigh | North Carolina | 27609 | — |
| Ardelyx Investigative Site 412 | Wilmington | North Carolina | 28403 | — |
| Ardelyx Investigative Site 414 | Bethlehem | Pennsylvania | 18017 | — |
| Ardelyx Investigative Site 404 | Columbia | South Carolina | 29203 | — |
| Ardelyx Investigative Site 421 | Orangeburg | South Carolina | 29118 | — |
| Ardelyx Investigative Site 428 | Sumter | South Carolina | 29150 | — |
| Ardelyx Investigative Site 413 | Knoxville | Tennessee | 37923 | — |
| Ardelyx Investigative Site 418 | Nashville | Tennessee | 37205 | — |
| Ardelyx Investigative Site 406 | Austin | Texas | 78758 | — |
| Ardelyx Investigative Site 405 | Bellville | Texas | 77418 | — |
| Ardelyx Investigative Site 422 | San Antonio | Texas | 78215 | — |
| Ardelyx Investigative Site 407 | San Antonio | Texas | 78229 | — |
| Ardelyx Investigative Site 401 | St. George | Utah | 84790 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02675998, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2020 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02675998 live on ClinicalTrials.gov.