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Treatment of Patients With Idiopathic Membranous Nephropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00135954
First received: August 25, 2005
Last updated: February 28, 2007
Last verified: February 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Glomerulonephritis, Membranous
 Drug: Cyclophosphamide and steroids
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • renal function (serum creatinine)
  • proteinuria
  • side effects

Estimated Enrollment: 30
Study Start Date: July 1997
Estimated Study Completion Date: June 2006
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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135954

Locations
Netherlands
Department of Nephrology Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Jack F Wetzels, MD, PhD Radboud University
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00135954     History of Changes
Other Study ID Numbers: RUNMN01
Study First Received: August 25, 2005
Last Updated: February 28, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
membranous nephropathy
cyclophosphamide
prednisone

Additional relevant MeSH terms:
Glomerulonephritis
Glomerulonephritis, Membranous
Kidney Diseases
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 19, 2013