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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
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.
Epistemonikos ID: 5ed40166f1734a1c206a875431f140ec59c5cb3d
First added on: May 21, 2024