A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of TRC101 in Subjects With Chronic Kidney Disease and Low Serum Bicarbonate Levels

Trial Profile

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of TRC101 in Subjects With Chronic Kidney Disease and Low Serum Bicarbonate Levels

Completed
Phase of Trial: Phase I/II

Latest Information Update: 02 Mar 2018

At a glance

  • Drugs TRC 101 (Primary)
  • Indications Acidosis; Kidney disorders; Renal failure
  • Focus Adverse reactions; First in man
  • Sponsors Tricida
  • Most Recent Events

    • 02 Mar 2018 According to a Tricida media release, the results of this and another phase III trial (see CT 280722) are intended to serve as the basis for the submission of a U.S. New Drug Application (NDA) for TRC101 under the Accelerated Approval Program of the U.S. Food and Drug Administration (FDA).
    • 08 Nov 2017 According to a Tricida media release, the results of this trial have been published in the Clinical Journal of the American Society of Nephrology (CJASN).
    • 01 Nov 2017 According to Tricida media release, data from this trial will be presented at ASN Kidney Week 2017 .
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