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, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal Disease

Trial Profile

A Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Feb 2023

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 Therapeutic Use
  • Acronyms NEFIGAN
  • Sponsors Calliditas Therapeutics; Pharmalink AB
  • Most Recent Events

    • 02 Feb 2023 According to Calliditas Therapeutics media release, the company announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression.
    • 19 May 2022 According to a Calliditas Therapeutics media release,the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending the granting of a conditional marketing authorisation for KinpeygoTM for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) =1.5 g/gram.A final decision by the EC on granting a marketing authorisation is anticipated in Q3 2022.
    • 22 Mar 2022 According to a Calliditas Therapeutics media release, the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2, 2022.
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