Mesangioproliferative IgA glomerulonephritis Urological and Genital Diseases Nephritic syndrome
Conditions
Interventions
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 suppo
Sponsors
Universitätsklinikum Ulm (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Secondary forms of IgAN e.g. anti-nuclear antibody positive (ANA+) lupus, anti-neutrophil cytoplasmic antibody positive (ANCA+) vasculitis, human immunodeficiency virus (HIV), liver cirrhosis 2. Rapidly progressive type three IgAN with crescents in greater than or equal to 30% of glomeruli 3. Serum creatinine less than 130 mcmol/l or greater than 400 mcmol/l after induction therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed