Treatment of Patients With Idiopathic Membranous Nephropathy
- Conditions
- Glomerulonephritis, Membranous
- Interventions
- Registration Number
- NCT00135954
- Lead Sponsor
- Radboud University Medical Center
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- Idiopathic membranous nephropathy
- Serum creatinine < 1.5 mg/dl
- Nephrotic syndrome
- Infection
- Instable angina
- Systemic disease
- Pregnancy
- Renal vein thrombosis
- Prior therapy with immunosuppressant agents
- Liver dysfunction
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description late intervention Cyclophosphamide and steroids cyclophosphamide and steroids started at time of renal insufficiency early intervention Cyclophosphamide and steroids immediate start of cyclophosphamide and steroids
- Primary Outcome Measures
Name Time Method renal function (serum creatinine) proteinuria side effects
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Nephrology Radboud University Nijmegen Medical Centre
🇳🇱Nijmegen, Netherlands
Department of Nephrology Radboud University Nijmegen Medical Centre🇳🇱Nijmegen, Netherlands