NCT03317444

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

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Tricida, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily. The maximum study duration is anticipated to be up to 16 weeks.

Conditions

• Metabolic Acidosis

Interventions

Type	Name	Description
DRUG	TRC101	Oral suspension
DRUG	Placebo	Oral suspension

Timeline

• Start date: 2017-09-26
• Primary completion: 2018-05-04
• Completion: 2018-05-15
• First posted: 2017-10-23
• Last updated: 2021-04-26
• Results posted: 2021-04-26

Locations

44 sites across 8 countries: United States, Bulgaria, Croatia, Georgia, Hungary, Serbia, Slovenia, Ukraine

Regulatory

• FDA-regulated drug study