Safety and Efficacy Study on Deoxyspergualin (NKT-01) in Patients With Uncontrolled Lupus Nephritis Receiving Oral Corticosteroids and Prior Treatment of Standard Immunosuppressive Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Complete and Partial Response Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
NKT-01
干预措施: NKT-01 (Drug)
结局指标
主要结局
Complete and Partial Response Rate
时间窗: Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks
A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to \<= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient.
次要结局
- SELENA-SLEDAI Score(Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks)
- Treatment Days With Corticosteroids of <= 7.5 mg/Day(1st and 9th Cycle)