Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- Change in serum creatinine
研究概览
简要总结
The investigators goal is to evaluate the role of XOLAIR® in treatment of Acute Tubulointerstitial Nephritis (AIN) with the goal of shortening the duration and dose of prednisone for treatment of drug-induced AIN. Currently there is no good treatment for drug-induced AIN. Prednisone is the standard treatment but is associated with many side-effects when used long-term and at high doses.
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
盲法说明
Open Label
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
- •Adult subjects > 18 years old of both genders
- •Biopsy proven acute interstitial nephritis in the native kidneys without evidence of ischemic or glomerular pathology in the biopsy
- •Normal baseline creatinine defined as estimated GFR ≥ 60 ml/min/SA based on MDRD calculation within 1 year prior to renal biopsy
- •Serum creatinine elevation of > 0.3 mg/dL and/or doubling of serum creatinine compared to most recent documented creatinine available (at least within the last year)
- •No immunosuppressants in the last three months including prednisone
- •Women of childbearing potential not using the contraception method can be included as this is a one time dosing and has no known long-term effects.
排除标准
- •Unwillingness to give consent
- •Patients who are Pregnant (positive serum pregnancy test for females) or breast feeding
- •Documented history of an autoimmune disease
- •Inability or unwillingness to take prednisone for the prescribed duration and/or dose
- •Subjects suspected to have non-drug-induced AIN
- •Subjects not meeting the inclusion criteria
- •Subjects with contraindication to administration of omalizumab
- •Prior use of omalizumab
- •Severe hypersensitivity to omalizumab or any component of the product
- •Known elevated IgE level from other disease processes
- •Subjects taking (nonsteroidal antiinflammatory drug) NSAIDs chronically
- •Use of any other investigational agents in the last 30 days
- •Patients with severe medical condition(s) including metastatic cancer, terminal congestive heart failure, severe ischemic heart disease or any other medical condition in which life expectancy is less than 6 months.
研究组 & 干预措施
Omalizumab and Prednisone
Omalizumab in addition to prednisone. Omalizumab will be given once subcutaneously at a dose of 375 mg within 24 hours after receiving prednisone
Standard clinical therapy with prednisone.
- Day 1-14: 60 mg/day 14 days (2 weeks)
- Day 15-28: 40 mg/day (2 weeks)
- Day 29-35: 30 mg/day (1 week)
- Day 36-42: 20 mg/day (1 week)
- Day 43-49: 10 mg/day (1 week)
- Day 50-56: 5 mg/day (1 week)
- Subjects will stop taking prednisone on day 57
If patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose).
干预措施: Omalizumab (Drug)
Omalizumab and Prednisone
Omalizumab in addition to prednisone. Omalizumab will be given once subcutaneously at a dose of 375 mg within 24 hours after receiving prednisone
Standard clinical therapy with prednisone.
- Day 1-14: 60 mg/day 14 days (2 weeks)
- Day 15-28: 40 mg/day (2 weeks)
- Day 29-35: 30 mg/day (1 week)
- Day 36-42: 20 mg/day (1 week)
- Day 43-49: 10 mg/day (1 week)
- Day 50-56: 5 mg/day (1 week)
- Subjects will stop taking prednisone on day 57
If patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose).
干预措施: Prednisone (Drug)
Prednisone
Standard clinical therapy with prednisone.
- Day 1-14: 60 mg/day 14 days (2 weeks)
- Day 15-28: 40 mg/day (2 weeks)
- Day 29-35: 30 mg/day (1 week)
- Day 36-42: 20 mg/day (1 week)
- Day 43-49: 10 mg/day (1 week)
- Day 50-56: 5 mg/day (1 week)
- Subjects will stop taking prednisone on day 57
If patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose).
干预措施: Prednisone (Drug)
结局指标
主要结局
Change in serum creatinine
时间窗: Baseline to three months
次要结局
- Mean individual percentage drop in serum creatinine relative to entry creatinine levels(baseline to 3 months)
- Percentage of subjects returning to their usual baseline creatinine (+25%) or below(baseline to 3 months)
- Reduction in Neutrophil gelatinase-associated lipocalcin.(baseline to 3 months)
- Percentage of subjects requiring renal replacement therapy(baseline to 3 months)