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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nippon Kayaku Co., Ltd.; Nippon Kayaku Co.,Ltd.
• Treatments: Gusperimus

Criteria

Inclusion Criteria:

• Males and females aged 18-70 years.

• A diagnosis of SLE according to the ACR criteria (at least 4/11 criteria).

• Sufficient signs to diagnose active SLE nephritis.

• Serum creatinine concentration of <= 5.0 mg/dL.

• Leucocyte counts >= 4000/uL.

• Receiving OCS (<= 1.0 mg/kg/day; a maximum dose of 80 mg/day).

• Prior treatment with cyclophosphamide, azathioprine, cyclosporin A, or any other immunosuppressive drugs.

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.