National Clinical Research Center of Kidney Diseases, Jinling Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Renal remission rate
研究概览
简要总结
In this study, we aimed to evaluate the long term efficacy, remission, survival and safety of autologous hematopoietic stem cell transplantation in patients with refractory lupus nephritis.
This is an single arm, non-randomized study. Patients who were diagnosed with relapsed and refractory lupus nephritis would included in this study. Refractory lupus nephritis is defined as no response to at least one type of immunosuppressant therapy (including corticosteroids, cyclophosphamide, tacrolimus, mycophenolate mofetil and cyclosporine) for more than six months, or relapse during the period maintenance therapy with kidney pathological transformation or persistently positive antibodies. Close observation was carried out at stem cell harvest, at transplantation, at 3, 6, 12, 18, and 24 months and then once a year after autologous stem cell transplantation.
20-30 cases will be included in this study.
详细描述
Treatment plan: Peripheral blood stem cells were mobilized with cyclophosphamide (2.0 g/m2) for 2 days and granulocyte colony-stimulating factor (G-CSF) at 5-10 μg/kg per day was administered when the level of peripheral leucocytes was < 1×109/L. Peripheral leukocyte counts were monitored, and harvesting was performed when the peripheral white blood cell level rebounded (usually 11 days after cyclophosphamide). The target acquisition was CD34+ cells > 2×10^6/kg and mononuclear cells > 2×10^8/kg. The graft was preserved at a temperature of -196 ℃ for further use. The conditioning regimen consisted of intravenous cyclophosphamide (40 mg/kg/day × 4 days) 5 days before transplantation (a total dose 160 mg/kg) and rabbit antithymocyte globulin (ATG) (2.5mg/kg/day × 3 days) 4 days before transplantation. The dose of cyclophosphamide and ATG could be reduced according to the patients' condition. Methylprednisolone (80-500 mg/day) was administered through intravenous drip at the same time with ATG to reduce anaphylaxis. The incidence of drug-related complications was decreased by hyperhydration (the volume of infusion liquid is 50 ml/kg/day), urine alkalization (infusion of sodium bicarbonate 250ml/day), and anti-emetic medication. G-CSF (0.5 μg/kg/d) was administered to each patient beginning the day after stem cells reinfusion until the level of absolute peripheral neutrophil count was consecutively higher than 1.0 × 10^9/L.
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
- 14 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with relapsed and refractory lupus nephritis;
- •Ages from 14 - 45 years old;
- •Serum creatinine < 2mg/dl;
- •Alanine aminotransferase < 2 times of normal upper limit;
- •Left ventricular ejection fraction > 50%;
- •Subjects (or their legal representatives) must signed an informed consent document.
排除标准
- •Active infection;
- •Known or suspected hypersensitivity to CTX or ATG;
- •Subjects suffering from uncontrolled or severe cardiovascular disease;
- •Subjects suffering from serious physical disease and mental illnesses.
研究组 & 干预措施
stem cell transplantation
patients enrolled in this study will received autologous hematopoietic stem cell transplantation as the initial treatment.
干预措施: Autologous hematopoietic stem cell transplantation (Procedure)
结局指标
主要结局
Renal remission rate
时间窗: seven years
The curative effect on the kidney was defined as follows: complete remission: proteinuria\< 0.4 g/24 h, red blood cell (RBC) \< 3/HP in urine sediment, serum albumin \> 3.5g/dl and serum creatinine \< 1.24 mg/dl; partial remission: 50% baseline \< decrease of proteinuria \< 3.5 g/24 h, serum albumin \>30g/L and serum creatinine \< 1.24 mg/dl, no remission (NR): failed to achieve partial remission
次要结局
- renal survival(seven years)
- treatment related mortality(3 months)
研究者
Zhi-Hong Liu, M.D.
Director
Nanjing University School of Medicine