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Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00404833
First Posted: November 29, 2006
Last Update Posted: October 23, 2013
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.
Collaborator:
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
  Purpose
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 Intervention Phase
Glomerulonephritis, Membranous Glomerulosclerosis, Focal Drug: prednisolone and mycophenolate mofetil Drug: prednisolone and chlorambucil Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • Proteinuria

Secondary Outcome Measures:
  • Adverse effects

Estimated Enrollment: 16
Study Start Date: January 2003
Study Completion Date: December 2006
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis
  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): NCT00404833


Locations
China
Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
The University of Hong Kong
Investigators
Principal Investigator: Daniel TM Chan, Prof Department of Medicine, Queen Mary Hospital
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00404833     History of Changes
Other Study ID Numbers: EC1838-02
HARECCTR0500005
First Submitted: November 27, 2006
First Posted: November 29, 2006
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:
Kidney Diseases
Glomerulonephritis
Glomerulosclerosis, Focal Segmental
Glomerulonephritis, Membranous
Urologic Diseases
Nephritis
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Prednisolone
Methylprednisolone Hemisuccinate
Chlorambucil
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs