Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

Phase 4

Completed

• Conditions: Lupus Nephritis; Lupus Erythematosus, Systemic

• Registration Number: NCT00125307
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-07-29
• Study First Submitted QC: 2005-07-29
• Study First Posted: 2005-08-01
• Primary Completion: 2007-10
• Study Completion: 2008-02
• Status Verified: 2008-05
• Last Update Submitted: 2015-07-31
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in 24-hour urinary protein excretion

Secondary Outcome Measures

Name	Time	Method
Development of non-renal flare
Development of renal flare

Trial Locations

Locations (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong