Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

This study has been completed.
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00404833
First received: November 27, 2006
Last updated: October 22, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00404833     History of Changes
Other Study ID Numbers: EC1838-02, HARECCTR0500005
Study First Received: November 27, 2006
Last Updated: October 22, 2013
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Glomerulonephritis
Glomerulosclerosis, Focal Segmental
Kidney Diseases
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Chlorambucil
Prednisolone
Methylprednisolone Hemisuccinate
Mycophenolic Acid
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolate mofetil
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 23, 2014