CTRI/2024/02/062336尚未招募Phase 3 4
Efficacy and safety of oral liposomal Iron versus conventional oral Iron In children with chronic kidney disease stage 3-5 with anemia- an open labelled randomised controlled.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Absolute increase in hemoglobin levels from baseline after 12 weeks
研究概览
简要总结
Children with chronic kidney disease (stages 3–5) with anemia who are not on dialysis or IV iron therapy will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: Less than or equal to 14 years
- •Chronic kidney disease not on hemodialysis
- •Anemia based on age and gender-specific values (KDIGO 2012)
- •Normal B12 and folate levels
- •Written informed consent.
排除标准
- •CKD on IV iron therapy
- •Hyperparathyroidism (iPTH >700 pg/mL)
- •Known haematological disorders
- •Bleeding or blood transfusions in the last 3 months.
结局指标
主要结局
Absolute increase in hemoglobin levels from baseline after 12 weeks
时间窗: 12 weeks
次要结局
- Proportion of children achieving specific target hemoglobin levels (11-12 g/dL)(12 weeks)
- Changes in hepcidin and low-density lipoprotein levels from baseline(12 weeks)
- Percentage increase in hemoglobin level(12 weeks)
- Change in iron profile (serum iron, serum transferrin, total(iron-binding capacity, ferritin, transferrin saturation) from baseline)
- Proportion of children with treatment emergent adverse events/severe adverse events(12 weeks)
研究者
Sunil Kushwah
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
研究点 (1)
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