Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary:
This is a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study will enroll approximately 130 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study will be conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) will continue for 14 days twice daily. In Part 2 study drug dosing (TRC101 or placebo) will continue for 14 days once daily.
The maximum study duration is anticipated to be up to 42 days.