Glomerulonephritis, Membranous
Conditions
Keywords
membranous nephropathy, cyclophosphamide, prednisone
Brief summary
Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.
Detailed description
Inclusion Criteria: * patients with idiopathic membranous nephropathy * nephrotic syndrome * normal renal function (serum creatinine \[Screat\] \< 1.5 mg/dl) * elevated urinary beta2-microglobulin and IgG Immunosuppressive therapy consisting of: * cyclophosphamide 1.5 mg/kg/day for 12 months * prednisone orally, 0.5 mg/kg on alternate days for 6 months * i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122 Study Groups: * early: immediate start of immunosuppressive therapy at the time patient is identified as high-risk * late: start of therapy after deterioration of renal function (increase of Screat \> 25% and Screat \> 1.5 mg/dl) Main Outcome Parameters: * serum creatinine * remission of proteinuria * period of nephrotic proteinuria * major side effects: hospitalisations, infections
Interventions
comparison of difference in time of start of therapy
Sponsors
Study design
Eligibility
Inclusion criteria
* Idiopathic membranous nephropathy * Serum creatinine \< 1.5 mg/dl * Nephrotic syndrome
Exclusion criteria
* Infection * Instable angina * Systemic disease * Pregnancy * Renal vein thrombosis * Prior therapy with immunosuppressant agents * Liver dysfunction * Use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal function (serum creatinine) | — |
| proteinuria | — |
| side effects | — |
Countries
Netherlands