Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
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.