At a glance
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A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of TRC101 in Subjects With Chronic Kidney Disease and Low Serum Bicarbonate Levels
In Brief
A Phase 2 clinical trial evaluating Placebo and TRC101 for Acidosis. Completed, enrolled 135 participants across 5 sites in 2 countries.
Detailed Summary
This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug dosing (TRC101 or placebo) continued for 14 days once daily (QD). The maximum study duration per subject was anticipated to be up to 42 days.
Study Details
Timeline
Interventions
oral suspension
oral suspension