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

NCT ID: NCT00404794

Last Updated: 2013-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lupus Nephritis Glomerulonephritis, Membranous

Keywords

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membranous lupus nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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prednisolone and mycophenolate mofetil

Intervention Type DRUG

prednisolone and tacrolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* abnormal urine protein excretion and biopsy-proven membranous lupus nephritis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Daniel TM Chan, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Queen Mary Hospital

Locations

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Queen Mary Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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HARECCTR0500003

Identifier Type: -

Identifier Source: secondary_id

UW05-205 T/868

Identifier Type: -

Identifier Source: org_study_id