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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

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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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 26 Mar 2020

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At a glance

  • Drugs Veverimer (Primary)
  • Indications Acidosis; Kidney disorders; Renal failure
  • Focus Adverse reactions; First in man; Registrational
  • Sponsors Tricida

Most Recent Events

  • 24 Mar 2020 Results published in the Tricida Media Release.
  • 24 Mar 2020 According to a Tricida media release, data from this trial will be presented at the Virtual National Kidney Foundation 2020 Spring Clinical Meetings.
  • 08 Aug 2019 According to a Tricida media release, based on company's pre-NDA meeting with the U.S. Food and Drug Administration (FDA), which included discussion of the positive TRCA-301E trial results, the company plans to submit a New Drug Application (NDA) seeking approval of TRC101 through the FDA's Accelerated Approval Program in the third quarter of 2019.

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