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A Phase 3 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Withdrawal Study Evaluating ADV7103 In Pediatric And Adult Subjects With Distal Renal Tubular Acidosis

Trial Profile

A Phase 3 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Withdrawal Study Evaluating ADV7103 In Pediatric And Adult Subjects With Distal Renal Tubular Acidosis

Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2018

At a glance

  • Drugs Potassium bicarbonate/potassium citrate (Primary)
  • Indications Renal tubular acidosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ARENA-2
  • Sponsors Advicenne
  • Most Recent Events

    • 12 Sep 2018 According to Advicenne media release, FDA has cleared its Investigational New Drug (IND) application to initiate a pivotal phase 3 clinical trial assessing ADV7103 in dRTA patients. The commercial launch in the United States is anticipated in 2021.
    • 05 Sep 2018 According to an Advicenne media release, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ADV7103, allowing the Company to formally initiate this pivotal trial.
    • 22 Aug 2018 Status changed from planning to not yet recruiting.
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