Sequential maintenance immunosuppression with mycophenolate and prednisolone: a randomised interventional trial in progressive immunoglobulin A nephritis (IgAN)

INTERVENTION: After enrolment phase, two patient groups are randomly assigned: 1. The mycophenolate group is treated with daily 2 x 360 mg oral mycophenolate combined with 2 x 2.5 mg oral prednisolone and the supportive standard therapy 2. The control group is treated with the supportive standard therapy alone consisting with an angiotensin‐converting‐enzyme inhibitor (ACEi) and/or an angiotensin receptor blocker (ARB) The maximum duration of treatment is 36 months and the total duration of follow‐up of all arms is 36 months. CONDITION: Mesangioproliferative IgA glomerulonephritis ; Urological and Genital Diseases ; Nephritic syndrome PRIMARY OUTCOME: The frequency of a GFR loss greater than 20% in the mycophenolate group and in controls. The loss is estimated by the difference from the best GFR after induction therapy. The primary end‐point will be measured at the end of month 36. SECONDARY OUTCOME: 1. Urinary protein/creatinine ratio; 2. Need for any further temporary or permanent medication (antihypertensives, antidiabetics, antiinfectives, etc.); 3. Hospitalisation; 4. Dialysis; 5. Death; ; All secondary end‐points will be measured every three months in each patient. INCLUSION CRITERIA: 1. Mesangioproliferative IgA glomerulonephritis in kidney biopsy 2. Steadily progressive type IgAN = loss of renal function of 2 to 3 ml/min per month before immunosuppressive induction therapy 3. Completion of any form of an immunosuppressive induction protocol (Pozzi, Ballardie, Rasche, experimental) 4. Still impaired renal function after induction therapy with a glomerular filtration rate (GFR) less than 60 ml/min 5. Aged between 18 and 68 years, either sex