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

This study is currently recruiting participants.

Verified by Hospital Authority, Hong Kong, June 2008

Sponsors and Collaborators:	Hospital Authority, Hong Kong The University of Hong Kong
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00404794

Purpose

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.

Condition	Intervention	Phase
Lupus Nephritis Glomerulonephritis, Membranous	Drug: prednisolone and mycophenolate mofetil Drug: prednisolone and tacrolimus	Phase III

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

Proteinuria

Secondary Outcome Measures:

Adverse effects

Estimated Enrollment:	20
Study Start Date:	November 2005
Estimated Study Completion Date:	October 2009

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

abnormal urine protein excretion and biopsy-proven membranous lupus nephritis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404794

Contacts

Contact: Daniel TM Chan, Prof

(852) 28554542

dtmchan@hkucc.hku.hk

Locations

China
Queen Mary Hospital	Recruiting
Hong Kong, China

Sponsors and Collaborators

Hospital Authority, Hong Kong

The University of Hong Kong

Investigators

Principal Investigator:

Daniel TM Chan, Prof

Department of Medicine, Queen Mary Hospital

More Information

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	UW05-205 T/868, HARECCTR0500003
Study First Received:	November 27, 2006
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00404794
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

membranous lupus nephritis

Study placed in the following topic categories:

Glomerulonephritis
Autoimmune Diseases
Methylprednisolone
Lupus Nephritis
Mycophenolic Acid
Glomerulonephritis, Membranous
Methylprednisolone acetate
Prednisolone acetate
Tacrolimus

Urologic Diseases
Lupus Erythematosus, Systemic
Nephritis
Prednisolone
Mycophenolate mofetil
Connective Tissue Diseases
Kidney Diseases
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Enzyme Inhibitors

Antibiotics, Antineoplastic
Immunosuppressive Agents
Protective Agents
Neuroprotective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009