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Mycophenolate Mofetil in Membranous Nephropathy

This study has been completed.
Hoffmann-La Roche
Information provided by:
Radboud University Identifier:
First received: August 25, 2005
Last updated: December 5, 2005
Last verified: August 2005

Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects.

In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.

Condition Intervention Phase
Glomerulonephritis, Membranous Drug: mycophenolate mofetil orally 1000 mg twice a day (BID) Drug: prednisone 0,5 mg/kg orally on alternate days Drug: intravenous (i.v.) methylprednisolone 1000 mg, total 9 Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study

Resource links provided by NLM:

Further study details as provided by Radboud University:

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

Secondary Outcome Measures:
  • side effects
  • relapse rate

Estimated Enrollment: 30
Study Start Date: May 2002

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Membranous nephropathy
  • Serum creatinine (Screat)> 1,5 mg/dl or ECC < 70 ml/min or increase Screat > 50%
  • Proteinuria > 2 g/day

Exclusion Criteria:

  • Systemic diseases
  • Pregnancy wish
  • Active infection
  • Liver dysfunction
  • Abnormal hematology lab
  • Unstable angina
  • Nonsteroidal anti-inflammatory agents (NSAIDs)
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Please refer to this study by its identifier: NCT00135967

Department of Nephrology Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Hoffmann-La Roche
Principal Investigator: Jack F Wetzels, MD Radboud University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00135967     History of Changes
Other Study ID Numbers: RUNMN02
Study First Received: August 25, 2005
Last Updated: December 5, 2005

Keywords provided by Radboud University:
membranous nephropathy
mycophenolate mofetil

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antiemetics processed this record on September 21, 2017