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Completed Phase 3 Interventional Results available

Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

ClinicalTrials.gov ID: NCT03317444

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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:55 PM EDT

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
Lead sponsor
Tricida, Inc.
Industry
Enrollment
217 participants

Conditions and interventions

Interventions

Drug

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 26, 2017 (Actual)
Primary completion
May 4, 2018 (Actual)
Completion
May 15, 2018 (Actual)
Last update posted
Apr 26, 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 26, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03317444 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →