Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Renal function in Thalassemia patients treated by Deferasirox
研究概览
简要总结
Thalassemia Major patients developed Iron Overload due to blood transfusions and intestinal iron absorption. Renal function caused by Iron overload was studied in a previous study and shows principally tubular disfunction. In this previous study the Iron chelator used was Deferrioxamine. In the last five years an oral Iron chelator was introduced and approved by the FDA, Deferasirox, (Novartis, Switzerland and USA). The purpose of this study is to assess the renal function in Thalassemia Major patients treated with this new oral iron chelator and compare the results with our previous study.
详细描述
Patients with Thalassemia Major. The laboratory tests that will be studied are: Urine dip stick, Urea, Creatinine, Na, K, Uric Acid, Calcium, Phosphorus in serum and urine, and N acetyl-b-D-glucosaminidase in Urine.Blood gases will be also taken in serum samples.
The overall iron accumulation will also be calculated based in the amount of Packed Cells Units transfused. The total iron burden will also assessed by measurement of Transferrin saturation and Serum Ferritin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Thalassemia Major or Intermedia treated by Iron chelators or by blood transfusions without treatment with iron chelators
- •Exclusion criteria:
- •None relevant
排除标准
- 未提供
研究组 & 干预措施
Deferasirox
The patients will be treated by the primary physician according to clinical status. The Deferasirox dose range is between 20 to 40 mg/kg/day once daily dose. The treatment is a continuous treatment and not a single course.
干预措施: Deferasirox (Drug)
结局指标
主要结局
Renal function in Thalassemia patients treated by Deferasirox
时间窗: One year study
Analysis of renal tubular function in patients treated by Deferasirox compared to patients treated by deferrioxamine
次要结局
未报告次要终点
研究者
Dr Koren Ariel
Head of Pediatric Dpt B and Pediatric Hematology Unit
HaEmek Medical Center, Israel