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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Nov 2017

At a glance

  • Drugs TRC 101 (Primary)
  • Indications Acidosis; Kidney disorders
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Tricida
  • Most Recent Events

    • 08 Nov 2017 According to a Tricida media release, the company plans to report topline results from this clinical trial in the second quarter of 2018.
    • 28 Sep 2017 According to a Tricida media release, if successful, data from this study will be used for the submission of a U.S. New Drug Application (NDA) for TRC101 under the FDA's accelerated approval pathway.
    • 28 Sep 2017 According to a Tricida media release, first patient has been enrolled.
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