Treatment of Patients With Idiopathic Membranous Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00135954
First received: August 25, 2005
Last updated: January 27, 2014
Last verified: February 2007
  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:


Further study details as provided by Radboud University:

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

Enrollment: 29
Study Start Date: July 1997
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
late intervention
cyclophosphamide and steroids started at time of renal insufficiency
Drug: Cyclophosphamide and steroids
comparison of difference in time of start of therapy
Other Names:
  • prednisolone
  • endoxan
Experimental: early intervention
immediate start of cyclophosphamide and steroids
Drug: Cyclophosphamide and steroids
comparison of difference in time of start of therapy
Other Names:
  • prednisolone
  • endoxan

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00135954     History of Changes
Other Study ID Numbers: RUNMN01
Study First Received: August 25, 2005
Last Updated: January 27, 2014
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, Membranous
Kidney Diseases
Glomerulonephritis
Urologic Diseases
Nephritis
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 September 16, 2014