Table 2.
Inclusions and exclusion criteria
| Inclusion criteria | Exclusion criteria |
|---|---|
| Age between 18 and 70 years | Chronic infection with HIV, Hepatitis B or Hepatitis C |
| Diagnosis of SLE according to the ACR criteria | Acute severe infection including fungal, viral, bacterial or protozoal diseases |
| 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) |
| 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) |
| Serum creatinine concentration of μ5.0 mg/dL | |
| Anemia (hemoglobulin <8.0 g/dL) | |
| Prior treatment with one or more immunosuppressive drugs (for example, CYC, AZA, methotrexate, cyclosporin A, MMF), or plasmapheresis | |
| Leukopenia (leukocytes <4,000/µL unless attributable to SLE: leukocytes <2,000/µL in these cases) | |
| Initial leukocyte count >4,000 cells/µL (unless leukopenia due to SLE disease activity: leukocyte count:/2,000/µL | |
| Thrombocytopenia (platelets <50,000/µL), | |
| Written informed consent | |
| Neutrophil counts below 1,000/µL | |
| Hypogammaglobulinemia (IgG below 400 mg/dl) | |
| Pregnancy or lactation | |
| Major and active SLE organ involvement other than the kidney, especially CNS involvement | |
| History of malignancy | |
| Participation in another clinical trial within six months before screening |
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.