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NCT00404794 Clinical Trial

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

Lupus Nephritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00404794
Other study ID # UW05-205 T/868
Secondary ID HARECCTR0500003
Status Completed
Phase Phase 3
First received November 27, 2006
Last updated October 22, 2013
Start date November 2005
Est. completion date October 2009

Study information
Verified date October 2013
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 2009
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- abnormal urine protein excretion and biopsy-proven membranous lupus nephritis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• prednisolone and mycophenolate mofetil

• prednisolone and tacrolimus

Locations
Country Name City State
China Queen Mary Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proteinuria
Secondary Adverse effects
See also
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