Table 2 |
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Inclusions and exclusion criteria |
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Inclusion criteria |
Exclusion criteria |
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Age between 18 and 70 years |
Chronic infection with HIV, Hepatitis B or Hepatitis C |
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Diagnosis of SLE according to the ACR criteria |
Acute severe infection including fungal, viral, bacterial or protozoal diseases |
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Signs of active SLE nephritis: increasing urinary protein excretion of 1 g or more per 24 hours (if initially normal values) or a further increase of >50% over the baseline proteinuria and/or active urinary sediment and/or impaired renal function due to SLE nephritis (newly elevated serum creatinine |
Signs of liver toxicity (WHO common toxicity criteria class 2 and higher) |
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If initially normal values - or >50% increase of serum creatinine levels if elevated before onset of renal flare), or signs of active LN in renal biopsy (any renal biopsy in the past two years) |
Absence of adequate liver function (total bilirubin >25 μmol/L = 1.4 mg/dL unless otherwise explained (for example, inherited, hemolysis), ALT or AST >2.5 times upper limit of normal values) |
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Serum creatinine concentration of μ5.0 mg/dL |
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Anemia (hemoglobulin <8.0 g/dL) |
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Prior treatment with one or more immunosuppressive drugs (for example, CYC, AZA, methotrexate, cyclosporin A, MMF), or plasmapheresis |
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Leukopenia (leukocytes <4,000/µL unless attributable to SLE: leukocytes <2,000/µL in these cases) |
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Initial leukocyte count >4,000 cells/µL (unless leukopenia due to SLE disease activity: leukocyte count:/2,000/µL |
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Thrombocytopenia (platelets <50,000/µL), |
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Written informed consent |
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Neutrophil counts below 1,000/µL |
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Hypogammaglobulinemia (IgG below 400 mg/dl) |
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Pregnancy or lactation |
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Major and active SLE organ involvement other than the kidney, especially CNS involvement |
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History of malignancy |
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Participation in another clinical trial within six months before screening |
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2 = difference of baseline EGFR minus minimum EGFR during DSG trial from entry ACR, American College of Rheumatology; AZA, azathioprin; CYC, cyclophosphamide; LN, lupus nephritis; MMF, mycophenolic acid; SLE, systemic lupus erythematosus. |
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Lorenz et al. Arthritis Research & Therapy 2011 13:R36 doi:10.1186/ar3268 |
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