NCT00404794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

First QC Date

November 27, 2006

Last Update Submit

October 22, 2013

Conditions

Lupus NephritisGlomerulonephritis, Membranous

Keywords

membranous lupus nephritis

Outcome Measures

Primary Outcomes (1)

  • Proteinuria

Secondary Outcomes (1)

  • Adverse effects

Interventions

prednisolone and mycophenolate mofetilDRUG
prednisolone and tacrolimusDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Lupus NephritisGlomerulonephritis, Membranous

Interventions

PrednisoloneMycophenolic AcidTacrolimus

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsMacrolidesLactones

Study Officials

  • Daniel TM Chan, Prof

    Department of Medicine, Queen Mary Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 29, 2006

Study Start

November 1, 2005

Study Completion

October 1, 2009

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

CN(1)