NCT00737711已完成4 期
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Treated With Erythropoietin-stimulating Agent (ESA).
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 189
- 主要终点
- Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
研究概览
简要总结
This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients, >=18 years of age;
- •chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
- •no prior erythropoietin stimulating agent (ESA) therapy.
排除标准
- •blood transfusion within the previous 4 weeks;
- •poorly controlled hypertension;
- •significant acute or chronic bleeding;
- •active malignant disease;
- •congestive heart failure (NYHA Class IV).
研究组 & 干预措施
Mircera
Experimental
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
时间窗: Baseline (Week 0) and Week 16
The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.
次要结局
- Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter(Up to Week 16)
- Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16(Week 12 to Week 16)
- Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16(Week 12 to Week 16)
- Number of Participants With Adverse Events, Serious Adverse Events and Deaths(Up to Week 18)
- Number of Participants With Abnormal Electrocardiogram(Up to Week 16)
- Number of Participants With Reports of Blood Transfusions(Up to Week 16)
- Number of Participants With Reports of Anti-Epoetin Antibodies(Up to Week 16)
- Mean White Blood Cell Count Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Value of Mean Corpuscular Volume Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Hypochromic Red Blood Cells Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Platelet Count Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Iron Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Ferritin Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Transferrin Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Total Iron-binding Capacity Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Transferrin Saturation Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Albumin Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Globulin Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Creatinine Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Blood Urea Nitrogen Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Potassium Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Sodium Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Phosphate Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Bilirubin Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Aspartate Transaminase Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Alanine Aminotransferase Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
- Mean Serum Alkaline Phosphatase Over Time(Baseline (Week 0), Week 4, Week 10, and Week 16)
研究者
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