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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

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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

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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.

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