Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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.

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 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top