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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135954
• Other study ID #: RUNMN01
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: January 27, 2014
• Start date: July 1997
• Est. completion date: July 2008

Study information

• Verified date: February 2007
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Intervention

Drug:
• Cyclophosphamide and steroids
comparison of difference in time of start of therapy

Locations

Country	Name	City	State
Netherlands	Department of Nephrology Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function (serum creatinine)
Primary	proteinuria
Primary	side effects