Back to resultsA Study to Compare Mycophenolate Mofetil and Tacrolimus in the Treatment of Membranous Lupus Nephritis
Primary Purpose
Lupus Nephritis, Glomerulonephritis, Membranous
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
prednisolone and mycophenolate mofetil
prednisolone and tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring membranous lupus nephritis
Eligibility Criteria
Inclusion Criteria:
- abnormal urine protein excretion and biopsy-proven membranous lupus nephritis
Sites / Locations
- Queen Mary Hospital
Outcomes
Primary Outcome Measures
Proteinuria
Secondary Outcome Measures
Adverse effects
Full Information
NCT ID
NCT00404794
First Posted
November 27, 2006
Last Updated
October 22, 2013
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00404794
Brief Title
A Study to Compare Mycophenolate Mofetil and Tacrolimus in the Treatment of Membranous Lupus Nephritis
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis, Glomerulonephritis, Membranous
Keywords
membranous lupus nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisolone and mycophenolate mofetil
Intervention Type
Drug
Intervention Name(s)
prednisolone and tacrolimus
Primary Outcome Measure Information:
Title
Proteinuria
Secondary Outcome Measure Information:
Title
Adverse effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
abnormal urine protein excretion and biopsy-proven membranous lupus nephritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel TM Chan, Prof
Organizational Affiliation
Department of Medicine, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare Mycophenolate Mofetil and Tacrolimus in the Treatment of Membranous Lupus Nephritis
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