The NEFIGAN trial is a randomized, double-blinded, placebo-controlled study assessing the safety and efficacy of two different doses of Nefecon. Nefecon was administered daily over a nine-month treatment period to primary IgAN patients at risk of renal failure despite optimized standard-of-care renin angiotensin system (RAS) blockade therapy. The trial was conducted at 62 centers in 10 European countries.
An interim analysis, conducted by the trial’s Data & Safety Monitoring Board in April 2015, demonstrated that Nefecon treatment met its primary efficacy endpoint. Nefecon treatment resulted in a highly significant improvement (p=0.0066 on an intention-to-treat basis) in the primary endpoint, defined as the mean reduction in urine protein creatinine ratio during the nine-month treatment period, as compared to placebo.