Acidosis Clinical Trial
Official title:
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
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.
n/a
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