Prolyl hydroxylase inhibitor(Desidustat) VS Erythropoiesis stimulating agent(Darbepoetin) in anemia of chronic kidney disease patients undergoing maintenance haemodialysis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients reaching target haemoglobin(Hb g/dl) who are receiving desidustat.
研究概览
简要总结
Erythropoiesis stimulating agents are currently the mainstay of treatment of anemia in chronic kidney disease .New approach in treatment of anemia in chronic kidney disease patients is the use of agents that stimulate endogenous erythropoietin production.Desidustat(Prolylhydroxylase inhibitor ) stimulate endogenous erythropoietin production.
Primary objective:To determine the effectiveness of prolyl hydroxylase inhibitor(Desidustat) in increasing haemoglobin levels in patients with anemia of chronic kidney disease undergoing maintenance haemodialysis.
Secondary objective:1.Comparing efficacy with darbepoetin
2.Comparision of safety with that of darbepoetin.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Maintenance Haemodialysis Patients with Hb8-11 g/dl in chronic kidney disease.
排除标准
- •Patient with iron deficiency anemia .
- •History of Bleeding disorders.
- •Red blood cell transfusion within 8 weeks prior to enrollment.
- •History of previous or concurrent cancer.
结局指标
主要结局
Proportion of patients reaching target haemoglobin(Hb g/dl) who are receiving desidustat.
时间窗: follow up at 4weeks 8weeks | & 12weeks
次要结局
- Saftey of desidustat.