Treatment of Patients With Idiopathic Membranous Nephropathy

Phase 3

Completed

• Conditions: Glomerulonephritis, Membranous
• Interventions: Drug: Cyclophosphamide and steroids

• 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

Study Timeline

• Study Start: 1997-07
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-26
• Status Verified: 2007-02
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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)

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

Trial Locations

Locations (1)

Department of Nephrology Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands