Treatment of Patients With Idiopathic Membranous Nephropathy

Radboud University Medical Center

Status and phase: Completed; Phase 3

Conditions: Glomerulonephritis, Membranous

Treatments: Drug: Cyclophosphamide and steroids

Study type: Interventional

Funder types: Other

Identifiers

NCT00135954

RUNMN01

Details and patient eligibility

About

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.

Full 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

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

late intervention

Other group

Description:

cyclophosphamide and steroids started at time of renal insufficiency

Treatment:

Drug: Cyclophosphamide and steroids

early intervention

Experimental group

Description:

immediate start of cyclophosphamide and steroids

Treatment:

Drug: Cyclophosphamide and steroids