An Open-label, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 39
- 主要终点
- Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
研究概览
简要总结
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram [mcg/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
- •chronic kidney disease, stage 3 or 4;
- •anemia (baseline hemoglobin between 9 and 11 grams per deciliter [g/dL]).
排除标准
- •previous therapy with ESA within 12 weeks prior to screening;
- •significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- •red blood cell transfusions within 8 weeks before screening;
- •active malignant disease (except non-melanoma skin cancer).
研究组 & 干预措施
Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
干预措施: Methoxy Polyethylene Glycol-epoetin Beta (Drug)
结局指标
主要结局
Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
时间窗: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)
The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.
次要结局
- Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP(EEP (Weeks 29 to 36))
- Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP(EEP (Weeks 29 to 36))
- Time to Achievement of Response(Baseline to Week 40)
- Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP(EEP (Weeks 29 to 36))