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Completed

NCT Number: NCT00404794

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

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.

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Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranous Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Queen Mary Hospital

Hong Kong, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

prednisolone and mycophenolate mofetil

Drug

prednisolone and tacrolimus

Drug

Primary outcomes

  1. Proteinuria

Secondary outcomes

  1. Adverse effects

Sponsors and collaborators

Lead sponsor

Hospital Authority, Hong Kong

Other Gov

Collaborators

  • The University of Hong Kong

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2009
First posted
Nov 29, 2006
Registry last updated
Oct 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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