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 Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd)

Trial Profile

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2019

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 Budesonide (Primary)
  • Indications IgA nephropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms NefIgArd
  • Sponsors Calliditas Therapeutics
  • Most Recent Events

    • 30 Sep 2019 According to an Calliditas Therapeutics media release, the EMA has provided positive guidance related to a CMA, in a written response from EMA, the agency agreed that it could support CMA assessment, subject as usual to the strength of the full data set presented at the time of filing, which will also include an analysis by Calliditas related to the likelihood of achieving success in Part B of this study. It also provided acceptance of the revised part B design.
    • 02 Sep 2019 According to an Calliditas Therapeutics media release, this study is being conducted at approximately 140 sites in 19 countries.
    • 02 Sep 2019 According to an Calliditas Therapeutics media release, read out of the full FDA approval on the design change of part B of the study is expected two years after last patient is randomized.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top