Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis

Exclusion Criteria

• •Chronic infection of HIV, Hepatitis B, Hepatitis C.
• •Acute infection including fungal, viral, bacterial or protozoal diseases.
• •Liver toxicity (WHO CTC class 2 and higher). No adequate liver function (total bilirubin \> 25 umol/L = 1.4 mg/dL unless explained otherwise (e.g. inherited, hemolysis), SGOT \> 2.5 x N, SGPT \> 2.5 x N).
• •Pregnant or lactating women
• •Female patients of child bearing age without safe method of contraception.
• •Anemia (hemoglobin \< 8.0 g/dL), leucopenia (leucocytes \< 4000/uL unless attributable to SLE: leucocytes \< 2000/uL), thrombocytopenia (platelets \< 50000/uL).
• •Neutrophils below 1000/uL.
• •Hypogammaglobulinemia below 400 mg/dL of serum IgG.
• •Any other condition that in the eyes of the investigator might have rendered the patient unsuitable for participation in the study. This especially includes major and active SLE organ involvement other than the kidney. Patients with SLE involvement of the central nervous system are not allowed to be included into the study.
• •History of malignancy.
• •Current participation in another trial or lass than 6 months since participation in a similar trial.