NCT00135954

Treatment of Patients With Idiopathic Membranous Nephropathy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Glomerulonephritis, Membranous

Interventions

Type	Name	Description
DRUG	Cyclophosphamide and steroids	comparison of difference in time of start of therapy

Timeline

• Start date: 1997-07-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2005-08-26
• Last updated: 2014-01-28

Locations

1 site across 1 country: Netherlands