Clinical Trial: Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
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.
Detailed Summary:
Sponsor: Tricida, Inc.
Current Primary Outcome: The primary objective of this first-in-human study is to evaluate the safety and tolerability of TRC101. The primary outcome measure is the comparison across dose groups of the cumulative percentage of treatment-emergent adverse events. [ Time Frame: Through study completion, up to 4 weeks. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: The secondary outcome measure is the change from baseline in serum bicarbonate to the end of 2-week treatment period within individual TRC101 dose group. [ Time Frame: Through treatment period completion, up to 2 weeks. ]
Original Secondary Outcome: The secondary outcome measure is to evaluate change from baseline in serum bicarbonate to the end of 2-week treatment period within individual TRC101 dose group. [ Time Frame: Through treatment period completion, up to 2 weeks. ]
Information By: Tricida, Inc.
Dates:
Date Received: June 14, 2016
Date Started: March 2016
Date Completion:
Last Updated: December 5, 2016
Last Verified: December 2016