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

This study has been completed.
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov 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 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 Intervention Phase
Lupus Nephritis
Glomerulonephritis, Membranous
Drug: prednisolone and mycophenolate mofetil
Drug: prednisolone and tacrolimus
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 A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Tacrolimus and Corticosteroid as Immunosuppressive Treatment for Lupus Membranous Nephritis

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: 20
Study Start Date: November 2005
Study Completion Date: October 2009

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

Inclusion Criteria:

  • abnormal urine protein excretion and biopsy-proven membranous lupus nephritis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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  HARECCTR0500003 
Study First Received: November 27, 2006
Last Updated: October 22, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
membranous lupus nephritis

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Lupus Nephritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Kidney Diseases
Lupus Erythematosus, Systemic
Urologic Diseases
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 30, 2016