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)
Phase of Trial: Phase III
Latest Information Update: 30 Sep 2019
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At a glance
- Drugs Budesonide (Primary)
- Indications IgA nephropathy
- Focus Registrational; Therapeutic Use
- Acronyms NefIgArd
- Sponsors Calliditas Therapeutics
- 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.