Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Rate of complete or partial response in lupus nephritis
研究概览
简要总结
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments
详细描述
Randomized, open, controlled, multicenter, clinical trial in patients with lupus nephritis previously treated with cyclophosphamide and mycophenolate. These patient can not have received Rituximab in the previous year. The number of patients estimated to reach statistical significance is 18 in each arm, a total sample size of 32 patients is needed.
The hypothesis is that the alternative procedure (a second cycle of Rituximab)will reduce the relapse rate of lupus nephritis and the consequent deterioration of renal function. Besides it will reduce health care expenses(hospitalization, medication, hemodialysis and renal transplantation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Both men and women between 18 and 70 years.
- •Patient with active lupus nephritis, previously treated with cyclophosphamide and mycophenolate (sodium or mofetil), who have not received rituximab in the previous year.
- •Women in childbearing age must have a pregnancy test in serum or urine negative and should use a contraceptive method suitable since at least 14 days prior to their inclusion in the study and up to 6 months after the last dose of the medication of the test.
- •Informed consent form signed.
排除标准
- •Patients treated with rituximab in the previous years
- •Active/sepsis serious infections
- •Renal biopsy showing interstitial fibrosis and/or glomerular over 75%.
- •Known neoplasia
- •Heart failure with III/IV functional class
- •Pregnancy
- •Known anaphylaxis to the product
- •History of hepatitis c
- •History of tuberculosis
- •Cardiovascular disease or uncontrolled hypertension
- •Chronic hepatitis B
- •Serious Cytopenia (granulocytes < 500/mm3, further < 10000/mm3)
- •Immunodeficiency (CVI, immunoglobulins deficiency)
- •Infection with HIV
研究组 & 干预措施
Rituximab (2 cycles)
A second cycle of Rituximab
First cycle of Rituximab (4 i.v. infusions):
Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2
Second cycle of Rituximab (4 i.v. infusions, 6 months later)
干预措施: Rituximab (Biological)
Rituximab (1 cycle)
1 cycle of Rituximab (4 i.v. infusions):
Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2
干预措施: Rituximab (Biological)
结局指标
主要结局
Rate of complete or partial response in lupus nephritis
时间窗: Assessment at 12 months
Complete response defined as: * Glomerular Filtration Rate (GFR)≥ 60, 73 m2 (or decline to baseline or ± 15% of baseline in those with GFR \<60 ml/min/1, 73m2). * Proteinuria ≤ 0.5 g/24 hours. * Inactive urine sediment (red cells, white cells, red cell casts according to local laboratory ranges). * Serum albumin\> 3 g / dl Partial response defined as: In patients with proteinuria ≥ 3.5 gr/24 h , decreased proteinuria \<3.5 gr/24 hours. * In patients with baseline proteinuria \<3.5 gr/24 hours, reduced proteinuria\> 50% of baseline. * In both situations, stabilization (± 25%) or reduce of the Glomerular Filtration Rate.
次要结局
- Rescue medication(24 months of follow-up)
- Efficacy(24 months of follow-up)
- Safety(24 months of follow-up)
- Renal function(24 months of follow-up)