NCT01169857撤回4 期
Velcade for Proliferative Lupus Nephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proteinuria
研究概览
简要总结
The primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.
详细描述
This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with WHO class III/IV/V lupus nephritis. Subjects will receive 12 doses of Velcade to induce clinical remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACR criteria for lupus (minimum 4 out of 11).
- •Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
- •GFR must be greater or equal to 30 cc/min/1.73 m
- •Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
- •Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.
排除标准
- •Serum creatinine of more than 3.0 mg/dL on repeated testing.
- •Greater than 50% fibrosis on renal biopsy.
- •Platelet count of less than 30× 109/L.
- •Absolute neutrophil count of less than 1.0 × 109/L.
- •Greater than or equal to Grade 1 peripheral neuropathy.
- •Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
- •Hypersensitivity to Velcade, boron or mannitol.
- •Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
- •Known history of untreated positive PPD.
- •Serious complications from systemic lupus such as cerebral lupus and severe active infections.
- •Diagnosed or treated for another malignancy within 3 years of enrollment.
- •Greater than 1.5x upper limit of normal total bilirubin.
研究组 & 干预措施
Velcade Therapy
Experimental
干预措施: Velcade (Drug)
结局指标
主要结局
Proteinuria
时间窗: 1 year
Quantification of 24 hr urinary protein.
次要结局
- Renal function(1 year)
- Lupus activity score(1 year)
研究者
研究点 (1)
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