Treatment of Patients With Idiopathic Membranous Nephropathy

Glomerulonephritis, Membranous Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, Membranous
• Kidney Diseases

• NCT number: NCT00135954
• Study type: Interventional
• Source: Radboud University
• Status: Completed
• Phase: Phase 3
• Start date: July 1997
• Completion date: July 2008