NCT02809183

Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Tricida, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acidosis

Interventions

Type	Name	Description
DRUG	Placebo	oral suspension
DRUG	TRC101	oral suspension

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-06-22
• Last updated: 2020-01-14
• Results posted: 2020-01-14

Locations

5 sites across 2 countries: Bulgaria, Georgia

Regulatory

• FDA-regulated drug study