Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

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

Detailed Description
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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.

Official Title
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Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

Conditions
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Lupus Nephritis, Lupus Erythematosus, Systemic

Intervention / Treatment
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* Drug: tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tacrolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour urinary protein excretion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of renal flare |  |  | 
| Development of non-renal flare |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, glomerulonephritis, immunosuppressive therapy, type V (membranous) lupus nephritis