At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 217 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.
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
In Brief
A Phase 3 clinical trial evaluating TRC101 and Placebo for Metabolic Acidosis. Completed, enrolled 217 participants across 44 sites in 8 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Acidosis
CountriesBulgaria, Croatia, Georgia, Hungary, Serbia, Slovenia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedOct 2017
Primary CompletionMay 2018
Study CompletionMay 2018
TodayJul 2026
First PostedOct 23, 2017
Enrollment StartSep 26, 2017
Primary CompletionMay 4, 2018
Study CompletionMay 15, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.7 years ago
Interventions
TRC101drug
Oral suspension
Placebodrug
Oral suspension