A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Participants With Remission of Renal Disease Activity at 3 Months
研究概览
简要总结
Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS patients develop kidney disease. The goal of this pilot study was to evaluate the safety and effectiveness of Rituximab in inducing remission of kidney disease in patients with CSS.
详细描述
Churg-Strauss syndrome (CSS) is a small vessel systemic vasculitis associated with asthma and eosinophilia that causes glomerulonephritis in about 25% of patients. Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes B cells and is effective in numerous autoimmune disease including antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The aim of this study was to evaluate the safety and efficacy of Rituximab in inducing remission of renal disease activity in patients with CSS.
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
- •Patients with Churg-Strauss syndrome as defined by meeting one of 3 sets of criteria for Churg-Strauss Syndrome described above who have not yet been treated, who have failed steroid therapy (partial or non-responders) or who can not been tapered off oral prednisone because of documented relapsing disease
- •Renal involvement (>25% dysmorphic red cell, red blood cell casts, or pauci-immune glomerulonephritis on biopsy)
- •Age >18 years old
- •Serum creatinine less than or equal to 3.0 mg/dl
- •Able and willing to give written informed consent and comply with the requirements of the study protocol.
- •Negative serum pregnancy test (for women of child bearing age)
- •Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment.
- •Exclusion Criteria
- •Severe obstructive or restrictive lung disease (forced expiratory volume in one second <1)
- •Cerebral involvement
- •Rapidly progressive optic neuropathy or retinal vasculitis
- •Active gastrointestinal bleeding
- •Heart failure, including pericarditis or myocarditis.
- •Hemoglobin <8.5 gm/dL
- •Platelets <100,000/mm
- •AST or ALT >2.5 Upper Limit of Normal unless related to primary disease
- •Positive Hepatitis B or C serology
- •History of positive HIV testing
- •Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
- •Previous treatment with Rituximab
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •History of recurrent significant infection or history of recurrent bacterial infections
- •Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- •Lack of peripheral venous access
- •History of drug, alcohol, or chemical abuse within 6 months prior to screening
- •Pregnancy or lactation
- •Concomitant malignancies or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
排除标准
- 未提供
研究组 & 干预措施
Rituximab
375 mg/m^2/week for 4 weeks
干预措施: Rituximab (Drug)
Rituximab
375 mg/m^2/week for 4 weeks
干预措施: Prednisone (Drug)
结局指标
主要结局
Participants With Remission of Renal Disease Activity at 3 Months
时间窗: 3 months after beginning of remission induction regimen
Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller)
次要结局
- Participants With Normalization of Eosinophil Count at 6 Months(6 months after beginning of remission induction regimen)
研究者
Fernando Fervenza
MD, PhD, Professor of Medicine
Mayo Clinic