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Table 2 Inclusions and exclusion criteria

From: Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study

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
  1. 2 = difference of baseline EGFR minus minimum EGFR during DSG trial from entry
  2. ACR, American College of Rheumatology; AZA, azathioprin; CYC, cyclophosphamide; LN, lupus nephritis; MMF, mycophenolic acid; SLE, systemic lupus erythematosus.