CTRI/2011/11/002153已完成1 期
A phase I/II, open label, single escalating dose study to assess safety, pharmacodynamics, pharmacokinetics and immunogenicity of polysialylated erythropoietin administered intravenously in chronic kidney disease patients who are on haemodialysis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects willing to give voluntary written informed consent.
- •2.Males >= 18 and <= 70 years of age and post-menopausal Females <= 70 years of age.
- •3.Clinically stable on hemodialysis for >= 3 months before screening (3 sessions per week).
- •4.Subjects with adequate dialysis ( as determined by Kt/V>=1.2 or URR>=65%) before enrollment.
- •5.Hemoglobin value of >=8g/dL and <= 11 g/dL within 14 days prior to administration of study drug
- •6.Serum ferritin level >= 200 µg/L and transferrin saturation >= 20% within 14 days prior to administration of study drug
- •7.RBC folate level and Vitamin B12 level above the lower limit of normal within 14 days prior to administration of study drug.
排除标准
- •1.Has received erythropoiesis stimulating agent in the last 6 weeks.
- •2.Blood transfusions within 4 weeks before screening or during the screening period or anticipated blood transfusion within one month after start of the study.
- •3.Nonrenal causes of anemia (e.g., Hemoglobinopathy [e.g., homozygous sickle cell disease, thalassemia of all types] , hemolysis, vitamin B12 or folic acid deficiency)
- •4.History suggestive of pure red cell aplasia (PRCA)
- •5.C Reactive Protein (CRP) greater than 15 mg/dL within 14 days prior to administration of study drug
- •6.Secondary hyperparathyroidism as evaluated by serum parathormone (PTH) level greater than 800pg/ml at screening.
- •7.Poorly controlled hypertension within 4 weeks prior to study drug administration, as per Investigators clinical judgment (e.g. systolic >= 170 mm Hg, diastolic >= 100 mm Hg on repeat readings)
- •8. Known intolerance to parenteral iron supplementation
研究者
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