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Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. This study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| advagraf | Experimental | Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-acting tacrolimus (Advagraf, Astellas Pharma) | Drug | Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| overall clinical response | complete response is defined as urinary protein < 0.5 g/day, with normal urinary sediment, normal serum albumin, and serum creatinine < 15% above the base-line value. Partial response is defined as urinary protein between 0.6 and 2.9 g/day, with a serum albumin > 30 g/dL, and stable renal function. No response is defined as urinary protein > 3 g/day or a value of 0.6 to 2.9 g/day but serum albumin < 30 g/dL, an increase in serum creatinine ≥ 50 µmol/l or 15% above the base-line value, or the discontinuation of treatment due to side effects. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in SLEDAI score | 6 months | |
| 24-hour urinary protein excretion | 6 months | |
| renal function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D005921 | Glomerulonephritis |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 6 months |
| development of lupus flare (renal or non-renal) | 6 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |