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Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

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. Identifier: NCT00404833
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : October 23, 2013
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong

Brief Summary:
This is a prospective randomized open-label pilot study to investigate the effect of mycophenolate mofetil treatment in patients with abnormal urine protein excretion due to membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS). The change in urine protein excretion will be the primary outcome studied. The treatment regimen comprising prednisolone and mycophenolate mofetil will be compared with prednisolone and chlorambucil in MN, and compared with prednisolone in FSGS. The study duration will be 12 months for each patient.

Condition or disease Intervention/treatment Phase
Glomerulonephritis, Membranous Glomerulosclerosis, Focal Drug: prednisolone and mycophenolate mofetil Drug: prednisolone and chlorambucil Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS)
Study Start Date : January 2003
Actual Study Completion Date : December 2006

Primary Outcome Measures :
  1. Proteinuria

Secondary Outcome Measures :
  1. Adverse effects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis

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 identifier (NCT number): NCT00404833

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Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
The University of Hong Kong
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Principal Investigator: Daniel TM Chan, Prof Department of Medicine, Queen Mary Hospital
Additional Information:
Layout table for additonal information Identifier: NCT00404833    
Other Study ID Numbers: EC1838-02
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013
Keywords provided by Hospital Authority, Hong Kong:
idiopathic membranous nephropathy or focal segmental glomerulosclerosis
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Glomerulosclerosis, Focal Segmental
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs