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Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

This study has been completed.
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong Identifier:
First received: November 27, 2006
Last updated: October 22, 2013
Last verified: October 2013
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: 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

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

Inclusion Criteria:

  • abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis
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Please refer to this study by its identifier: NCT00404833

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

Additional Information: Identifier: NCT00404833     History of Changes
Other Study ID Numbers: EC1838-02
Study First Received: November 27, 2006
Last Updated: October 22, 2013

Keywords provided by Hospital Authority, Hong Kong:
idiopathic membranous nephropathy or focal segmental glomerulosclerosis

Additional relevant MeSH terms:
Kidney Diseases
Glomerulosclerosis, Focal Segmental
Glomerulonephritis, Membranous
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone Hemisuccinate
Mycophenolic Acid
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolate mofetil
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Autonomic Agents processed this record on May 23, 2017