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A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects with Chronic Kidney Disease and Metabolic Acidosis

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Trial Profile

A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects with Chronic Kidney Disease and Metabolic Acidosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Dec 2021

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At a glance

  • Drugs Veverimer (Primary)
  • Indications Metabolic acidosis; Renal failure
  • Focus Adverse reactions; Registrational
  • Sponsors Tricida

    • Most Recent Events

    • 07 Jul 2021 Results of post hoc subgroup analysis evaluated effects of veverimer on metabolic acidosis and physical function among patients with diabetes published in the Nephrology Dialysis Transplantation
    • 10 Feb 2021 According to a Zhang Investor Law media release, a class action lawsuit has been filled on behalf of shareholders of Tricida. According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that, Tricida's NDA for veverimer was materially deficient; accordingly, it was foreseeably likely that the FDA would not accept the NDA for veverimer; and hence, the Company's public statements were materially false and misleading.
    • 08 Dec 2020 'According to a Tricida media release, if accepted for consideration, a decision on the FDRR is expected in the first quarter of 2021. The timing and next steps for a resubmission of the NDA for veverimer will be dependent upon the OND's decision.

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