NCT03390842

Long-term Safety Extension to Study TRCA-301

A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Tricida, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.

Conditions

• Metabolic Acidosis

Interventions

Type	Name	Description
DRUG	TRC101	Oral suspension
DRUG	Placebo	Oral suspension

Timeline

• Start date: 2017-12-20
• Primary completion: 2019-02-22
• Completion: 2019-02-22
• First posted: 2018-01-04
• Last updated: 2021-10-22
• Results posted: 2021-10-22

Locations

29 sites across 7 countries: United States, Bulgaria, Georgia, Hungary, Serbia, Slovenia, Ukraine

Regulatory

• FDA-regulated drug study