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A Study to Compare Mycophenolate Mofetil and Tacrolimus in the Treatment of Membranous Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT00404794
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : October 23, 2013
Information provided by:

Study Description
Brief Summary:
This is a prospective randomized open-label pilot study to compare mycophenolate mofetil in combination with corticosteroid treatment and tacrolimus in combination with corticosteroid treatment in membranous lupus nephritis. The change in urine protein excretion will be the primary outcome studied. The study duration will be 24 months for each patient.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Glomerulonephritis, Membranous Drug: prednisolone and mycophenolate mofetil Drug: prednisolone and tacrolimus Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Tacrolimus and Corticosteroid as Immunosuppressive Treatment for Lupus Membranous Nephritis
Study Start Date : November 2005
Study Completion Date : October 2009

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Proteinuria

Secondary Outcome Measures :
  1. Adverse effects

Eligibility Criteria

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

Inclusion Criteria:

  • abnormal urine protein excretion and biopsy-proven membranous lupus nephritis
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): NCT00404794

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:
ClinicalTrials.gov Identifier: NCT00404794     History of Changes
Other Study ID Numbers: UW05-205 T/868
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:
membranous lupus nephritis

Additional relevant MeSH terms:
Lupus Nephritis
Glomerulonephritis, Membranous
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents