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. ]

The number and percentage of subjects who reported treatment-emergent adverse events will be summarized by system organ class and preferred term; as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses will be descriptive.


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. ]

Efficacy data will be summarized by dose group based on the randomized treatment group assignment. Descriptive statistics of efficacy data will be provided for all scheduled time points.


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. ]

Efficacy data will be summarized by dose group based on the randomized treatment group assignment. Descriptive statistics of efficacy data will be provided for all scheduled time points.


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