Leflunomide treatment in progressive Immunoglobulin A Nephropathy (IgAN), a multi-centre, prospective, randomised controlled study

INTERVENTION: Please note that as of 02/07/2007, the anticipated end date of this trial has been extended to 31/12/2007. The anticipated end date of this trial was again extended on 08/04/2008 to 31st June 2008 ‐ this is due to problems with recruitment. After enrolment, patients are randomised to prednisone or prednisone together with leflunomide for one year and then followed up for two years. CONDITION: Progressive Immunoglobulin A (IgA) nephrology ; Urological and Genital Diseases ; Progressive Immunoglobulin A (IgA) nephrology PRIMARY OUTCOME: Loss of renal function (defined as serum creatinine increased by 200% or a reduce of 50% in the estimated GFR) SECONDARY OUTCOME: Discontinuation of therapy due to adverse effect INCLUSION CRITERIA: 1. Age 18‐65 years 2. Renal biopsy diagnosed primary IgAN in three months before enrolment and proteinuria more than one gram per 24 hours, in conjunction with a decreased renal function at diagnosis (estimated Glomerular Filtration Rate [GFR] less than 60 ml/min and more than 29 ml/min, evaluated by the Modification in Diet of Renal Disease [MDRD] equation) and/or histological unfavorable criteria (Lee?s classification grade II to IV) 3. Written informed consent