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

Nippon Kayaku

Status and phase

Completed

Phase 2

Phase 1

Conditions

Lupus Nephritis

Treatments

Drug: NKT-01

Study type

Interventional

Funder types

Industry

Identifiers

NCT00709722

SLE01-ENK

Details and patient eligibility

About

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.

Full description

The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC < 2x10^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore 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.

Enrollment

21 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.