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A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis

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Trial Profile

A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Nov 2019

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At a glance

  • Drugs Veverimer (Primary)
  • Indications Metabolic acidosis; Renal failure
  • Focus Registrational; Therapeutic Use
  • Acronyms VALOR-CKD
  • Sponsors Tricida

    • Most Recent Events

    • 14 Nov 2019 According to a Tricida media release, 95% of the approximately 350 targeted sites are open for enrollment and enrollment is expected to complete in mid-2020.
    • 08 Aug 2019 According to a Tricida media release, the overall status and rate of enrollment of this trial were deemed sufficient by the FDA for the company to plan for the NDA submission for veverimer in the third quarter of 2019. The company intends to provide an update by the end of 2019 on its estimate for enrolling the last patient in its postmarketing trial.
    • 25 Oct 2018 New trial record
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