TY - T1 - Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN) : a double-blind, randomised, placebo-controlled phase 2b trial SN - / UR - http://hdl.handle.net/10138/236232 T3 - A1 - Fellstroem, Bengt C.; Barratt, Jonathan; Cook, Heather; Coppo, Rosanna; Feehally, John; de Fijter, Johan W.; Floege, Juergen; Hetzel, Gerd; Jardine, Alan G.; Locatelli, Francesco; Maes, Bart D.; Mercer, Alex; Ortiz, Fernanda; Praga, Manuel; Sorensen, Soren S.; Tesar, Vladimir; Del Vecchio, Lucia; NEFIGAN Trial Invest A2 - PB - Y1 - 2017 LA - eng AB - Background IgA nephropathy is thought to be associated with mucosal immune system dysfunction, which manifests as renal IgA deposition that leads to impairment and end-stage renal disease in 20-40% of patients within 10-20 years. In this trial (NEFIGAN) we aimed to assess safety and efficacy of a novel targeted-release formulation of budesonide (TRF-budesonide), designed to deliver the drug to the distal ileum in patients with IgA nephropathy. Methods We did a randomised, double-blind, placebo-c... VO - IS - SP - OP - KW - IMMUNOGLOBULIN-A NEPHROPATHY; LONG-TERM; RENAL SURVIVAL; KIDNEY-DISEASE; RISK; THERAPY; PHARMACOKINETICS; PROTEINURIA; ANTIBODIES; HEMATURIA; 3121 General medicine, internal medicine and other clinical medicine N1 - PP - ER -