Last updated on November 2019

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

Brief description of study

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 Study 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 average duration of follow-up is anticipated to be 3.5 years.

Clinical Study Identifier: NCT03710291

Find a site near you

Start Over

Investigative Site 4123

Hollywood, FL United States
  Connect »

Investigative Site 4122

Hollywood, FL United States
  Connect »

Investigative Site 4153

Fort Lauderdale, FL United States
  Connect »

Investigative Site 4133

Lauderdale Lakes, FL United States
  Connect »

Investigative Site 4144

Miami Gardens, FL United States
  Connect »

Investigative Site 4104

Miami, FL United States
  Connect »