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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

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: 14 Nov 2019

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At a glance

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

    • 14 Nov 2019 According to a Tricida media release, Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting is anticipated in the first half of 2020.
    • 14 Nov 2019 According to a Tricida media release, data from this trial were presented at the ASN Kidney Week 2019 Meeting.
    • 14 Nov 2019 According to a Tricida media release, the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for veverimer under the Accelerated Approval Program and stated that no filing review issues were identified. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 22, 2020 and FDA is planning to hold a Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting to discuss the application.
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