CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 196 enrolled
Drug / intervention
TRC101 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03390842
NCT03390842Phase 3Completed
CompareCT.gov

A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

Tricida, Inc.·interventional·Posted Jan 4, 2018·Updated Oct 22, 2021

In Brief

A Phase 3 clinical trial evaluating TRC101 and Placebo for Metabolic Acidosis. Completed, enrolled 196 participants across 29 sites in 7 countries.

Detailed Summary

This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Acidosis
CountriesBulgaria, Georgia, Hungary, Serbia, Slovenia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 4, 2018
Enrollment StartDec 20, 2017
Primary CompletionFeb 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.5 years ago

Interventions

TRC101drug

Oral suspension

Placebodrug

Oral suspension