Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin as Erythropoietic Agents for Treatment of Anemia in Pediatric Chronic Kidney Disease Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change in hemoglobin (Hb) between baseline and the evaluation period
研究概览
简要总结
The present study was designed to determine whether or not darbepoetin alfa is non-inferior to recombinant human erythropoietin in the treatment of anemia in children with chronic kidney disease stage 3-5 (on or not on dialysis).
详细描述
PRIMARY OBJECTIVE:
To demonstrate that Darbepoetin alpha is non-inferior to erythropoietin for the treatment of anemia in subjects with chronic kidney disease (CKD) stage 3-5 (on or not on dialysis).
SECONDARY OBJECTIVE:
To determine the safety and tolerability of Darbepoetin alpha in the treatment of anemia in the pediatric population with CKD stage 3-5.
STUDY DESIGN:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-18 years.
- •CKD patients stages 3 to 5 (on or not on dialysis).
- •Baseline hemoglobin 9 - 12 g/dL.
- •Subject should have adequate transferrin saturation (≥20%) and serum ferritin (≥100 ng/mL).
- •Stable erythropoietin therapy for 8 weeks ( defined as a ≤25% change in prescribed dose, no change in the route of administration and no more than one missed or withheld dose).
排除标准
- •Subject scheduled for a living-related kidney transplant.
- •Subject with uncontrolled hypertension.
- •HIV positive patient.
- •The patient with known hematologic disease or cause of anemia other than renal disease.
- •Patient with a history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrolment.
- •Hyperparathyroidism (Intact parathyroid hormone more than 1500 pg/ml or biopsy proven marrow fibrosis).
- •Major surgery within 12 weeks.
- •Active inflammatory disease within 8 weeks of randomization requiring immunosuppressive therapy.
- •Clinical evidence of malignancy.
- •Blood transfusion within 8 weeks prior to initiation of therapy.
研究组 & 干预措施
Erythropoietin
Recombinant Human Erythropoietin
干预措施: Recombinant human erythropoietin (Drug)
Darbepoetin alfa
Darbepoetin Alpha
干预措施: Darbepoetin Alfa (Drug)
结局指标
主要结局
Mean change in hemoglobin (Hb) between baseline and the evaluation period
时间窗: 24 -28 week
Hb in mg/dL
次要结局
- Incidence of treatment-related adverse events in both groups during study period(0-28 week)
研究者
Rufaida Mazahir
Principal Investigator
Sir Ganga Ram Hospital