Status:
COMPLETED
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
Lead Sponsor:
Nippon Kayaku Co., Ltd.
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed 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\...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00709722
Start Date
October 1 2003
End Date
April 1 2007
Last Update
January 10 2017
Active Locations (6)
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1
General Faculty Hospital
Prague, Czechia, 12808
2
Universitatsklinikum Charite
Berlin, Germany, 10117
3
Universitat Frankfurt
Frankfurt, Germany, 60590
4
University of Heidelberg
Heidelberg, Germany, 69120