Comparative Study Between Chloroquine and Hydroxychloroquine as Therapeutic Modalities for Children and Adolescents With Proliferative Lupus Nephritis
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fundus examination as screening test
研究概览
简要总结
Evaluation the efficacy of chloroquine and hydroxychloroquine in the treatment of proliferative lupus nephritis class III and IV in children and adolescents and evaluate the side effects of both drugs .
详细描述
All patients will fulfill the diagnostic criteria of SLE. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. The criteria set developed by the American College of Rheumatology (ACR) and diagnosed wih lupus nephritis class III and IV .
Inclusion Criteria:
- Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.
- All patients will be received steroids , MMF and Angiotensin Converting Enzyme.
Exclusion Criteria:
- Patients diagnosed with lupus nephritis class I,II,V and VI.
- Patients received Cyclophosphamide in stead of MMF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.
- •All patients will be received steroids , MMF and Angiotensin Converting Enzyme.
排除标准
- •Patients diagnosed with lupus nephritis class I,II,V and VI.
- •Patients received Cyclophosphamide in stead of MMF.
研究组 & 干预措施
Lupus nephritis III or IV/chloroquine
receiving chloroquine with daily dose 5 mg/kg
干预措施: Chloroquine (Drug)
Lupus nephritis III or IV/hydroxychloroquine
receiving hydroxycholorquine with daily dose 5 mg/kg
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Fundus examination as screening test
时间窗: 12 months
Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage.
次要结局
未报告次要终点
研究者
Fatma Sayed Ahmed Gheet
Resident Pediatercian
Tanta University