NCT03710291

Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,480 (actual)
• Sponsor: Tricida, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

Detailed description

This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in eGFR, end-stage renal disease (ESRD), and renal death. The study will terminate when the independent blinded Clinical Endpoint Adjudication Committee has positively adjudicated the targeted number of primary efficacy endpoint events. The maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.

Conditions

• Metabolic Acidosis
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	TRC101	Oral, non-absorbed, polymeric hydrochloric acid binder
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2018-11-20
• Primary completion: 2022-08-23
• Completion: 2022-09-27
• First posted: 2018-10-18
• Last updated: 2022-10-14

Locations

203 sites across 34 countries: United States, Albania, Argentina, Armenia, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, France, Georgia, Hong Kong, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, North Macedonia, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, South Korea, Spain, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study