A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients Not Currently Treated With ESA.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period
研究概览
简要总结
This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. 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
- •adult patients, >=18 years of age;
- •chronic renal anemia;
- •predialysis stage;
- •no ESA therapy during previous 3 months.
排除标准
- •transfusion of red blood cells during previous 2 months;
- •poorly controlled hypertension requiring hospitalization in previous 6 months;
- •significant acute or chronic bleeding.
研究组 & 干预措施
Continuous erythropoietin receptor activator (C.E.R.A.)
Eligible participants will be administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. will be 1.2 micrograms/kilogram. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin within the target range of 10.0 and 12.0 grams/deciliter.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period
时间窗: From Baseline (Week 0) to EEP (Week 29 to Week 36)
Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP \[Week 29 to Week 36\]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.
次要结局
- Number of Participants Who Received Red Blood Cell Transfusions During the Study Period(Up to Week 52)
- Mean Time to Achievement of Response During the EEP(From Week 29 to Week 36)
- The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP(From Week 29 to Week 36)
- Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP(From Week 29 to Week 36)
- Mean Change From Baseline in Hematocrit Level Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, and 48)
- Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP(Weeks 0 to Week 36)
- Mean Change From Baseline in C-Reactive Protein Concentration Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48)
- Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events(Up to Week 52)
- Mean Change From Baseline in Hb Concentration Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in Albumin Concentration Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in Creatinine Concentration Over Time(Baseline (Week 0), Weeks 8, 16, 32, 40)
- Mean Change From Baseline in Ferritin Concentration Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in Transferrin Saturation Over Time(Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48)