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

Completed

Conditions: Mesangioproliferative IgA glomerulonephritis
Urological and Genital Diseases
Nephritic syndrome

Registration Number: ISRCTN74038076

Lead Sponsor: niversitätsklinikum Ulm (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 70

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1. Urinary protein/creatinine ratio<br>2. Need for any further temporary or permanent medication (antihypertensives, antidiabetics, antiinfectives, etc.)<br>3. Hospitalisation<br>4. Dialysis<br>5. Death<br><br>All secondary end-points will be measured every three months in each patient.