Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00125307

Purpose

The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.

Condition	Intervention	Phase
Lupus Nephritis Lupus Erythematosus, Systemic	Drug: tacrolimus	Phase IV

MedlinePlus related topics: Lupus

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Change in 24-hour urinary protein excretion

Secondary Outcome Measures:

Development of renal flare
Development of non-renal flare

Estimated Enrollment:	20
Study Start Date:	January 2004
Study Completion Date:	February 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). The treatment of membranous (type V) lupus nephritis, a subset that carries a high morbidity, remains unsatisfactory. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cells, for example, tacrolimus, may be effective in the treatment of primary membranous nephropathy. The investigators plan to conduct an open-label single-arm study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy secondary to SLE. Twenty patients with biopsy-proven membranous nephropathy secondary to SLE will be recruited. They will be treated with oral prednisolone and tacrolimus for 6 months, followed by 6 months of maintenance steroids alone. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.5 gm/day. This study will explore the potential role of tacrolimus in the treatment of membranous lupus nephritis, which is usually resistant to conventional therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Fulfill the revised American College of Rheumatology criteria for SLE
Have biopsy-proven membranous nephropathy secondary to SLE
Nephrotic syndrome with proteinuria (> 3 g/day) and serum albumin < 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents)
Age over 18 with informed consent
Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study

Exclusion Criteria:

Patient with abnormal liver function tests
Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
Patient who is diabetic
Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion
Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125307

Locations

China
Department of Medicine & Therapeutics, Prince of Wales Hospital
Hong Kong, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Cheuk-Chun Szeto, MD

Chinese University of Hong Kong

More Information

Study ID Numbers:	CRE-2004.229-T, CRE-2004.229-T
Study First Received:	July 29, 2005
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00125307
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee; Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:

SLE
glomerulonephritis
immunosuppressive therapy
type V (membranous) lupus nephritis

Study placed in the following topic categories:

Glomerulonephritis
Autoimmune Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Lupus Nephritis

Nephritis
Connective Tissue Diseases
Tacrolimus
Kidney Diseases

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009