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A multicentre, open-label, non-inferiority sequential study, evaluating the efficacy, safety, tolerability and acceptability of ADV7103 compared to standard of care in distal renal tubular acidosis patients.

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Trial Profile

A multicentre, open-label, non-inferiority sequential study, evaluating the efficacy, safety, tolerability and acceptability of ADV7103 compared to standard of care in distal renal tubular acidosis patients.

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 23 May 2021

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At a glance

  • Drugs Potassium bicarbonate/potassium citrate (Primary) ; Potassium bicarbonate; Potassium citrate; Sodium bicarbonate; Sodium citrate
  • Indications Metabolic acidosis; Renal tubular acidosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Advicenne

Most Recent Events

  • 17 May 2021 According to an Advicenne media release, the the European Medicines Agency (EMA) has approved the Marketing Authorization Application (MAA) for ADV7103 as a treatment for distal renal tubular acidosis (dRTA).
  • 12 Mar 2019 According to an Advicenne media release, based on the data from B21CS and B22CS studies, the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ADV7103, as a treatment for distal renal tubular acidosis (dRTA). Marketing authorization for ADV7103 is anticipated in mid-2020.
  • 11 Sep 2017 Topline data were presented at the 50th European Society of Paediatric Nephrology (ESPN) 2017 Annual Meeting.

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