Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
Public ClinicalTrials.gov record NCT03317444. 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
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily. The maximum study duration is anticipated to be up to 16 weeks.
Study identification
- NCT ID
- NCT03317444
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 217 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 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
- Sep 25, 2017
- Primary completion
- May 3, 2018
- Completion
- May 14, 2018
- Last update posted
- Apr 25, 2021
2017 – 2018
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigative Site 55 | Phoenix | Arizona | 85032 | — |
| Investigative Site 56 | Chula Vista | California | 91910 | — |
| Investigative Site 91 | Los Angeles | California | 90022 | — |
| Investigative Site 59 | Hialeah | Florida | 33015 | — |
| Investigative Site 54 | Hollywood | Florida | 33021 | — |
| Investigative Site 93 | Hollywood | Florida | 33024 | — |
| Investigative Site 92 | Lauderdale Lakes | Florida | 33313 | — |
| Investigative Site 51 | Tampa | Florida | 33614 | — |
| Investigative Site 57 | Winter Park | Florida | 32789 | — |
| Investigative Site 95 | Atlanta | Georgia | 30342 | — |
| Investigative Site 53 | Shreveport | Louisiana | 71101 | — |
| Investigative Site 58 | Flushing | New York | 11355 | — |
| Investigative Site 52 | San Antonio | Texas | 78215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03317444, 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 Apr 25, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03317444 live on ClinicalTrials.gov.