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

This study has been completed.
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00404794
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 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
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

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
  Eligibility

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 membranous lupus nephritis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404794

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: NCT00404794     History of Changes
Other Study ID Numbers: UW05-205 T/868
HARECCTR0500003
Study First Received: November 27, 2006
Last Updated: October 22, 2013

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

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Glomerulonephritis
Glomerulonephritis, Membranous
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
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
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on September 21, 2017