Treatment of Patients With Idiopathic Membranous Nephropathy

Study Overview
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Brief Summary
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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
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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

Official Title
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Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy

Conditions
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Glomerulonephritis, Membranous

Intervention / Treatment
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* Drug: Cyclophosphamide and steroids


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: late intervention<br>cyclophosphamide and steroids started at time of renal insufficiency | Drug: Cyclophosphamide and steroids<br>* comparison of difference in time of start of therapy<br>* Other names: endoxan;|
| Experimental: early intervention<br>immediate start of cyclophosphamide and steroids | Drug: Cyclophosphamide and steroids<br>* comparison of difference in time of start of therapy<br>* Other names: endoxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function (serum creatinine) |  |  | 
| proteinuria |  |  | 
| side effects |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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membranous nephropathy, cyclophosphamide, prednisone