We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 52 for:    "Membranous nephropathy"

Treatment of Patients With Idiopathic Membranous Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135954
First Posted: August 26, 2005
Last Update Posted: January 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radboud University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 25, 2005
First Posted: August 26, 2005
Last Update Posted: January 28, 2014
Last Verified: February 2007

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
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists