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
Price :
$35
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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
- 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.