The NEFIGAN Trial
Research type
Research Study
Full title
A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease
IRAS ID
111313
Contact name
Alan G Jardine
Contact email
Sponsor organisation
Pharmalink AB
Eudract number
2012-001923-11
Clinicaltrials.gov Identifier
Research summary
A study to assess if two different doses of Nefecon (budesonide modifed released) capsules taken as a capsule are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease. There are many kidney diseases that cannot be cured with the medications available today. In IgA nephropathy patients, the kidneys become inflamed and damaged by IgA that gets trapped in the kidneys. IgA stands for immunoglobulin A, which is type of antibody that normally helps your body fight off infections. The drug being studied is specifically designed to release budesonide in specific part of the gut to reduce the production of IgA in the gut in order to reduce the amount of IgA getting into the blood and that then gets trapped in the kidney.
REC name
West of Scotland REC 1
REC reference
12/WS/0230
Date of REC Opinion
6 Nov 2012
REC opinion
Further Information Favourable Opinion