Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 393
- 试验地点
- 12
- 主要终点
- Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9
研究概览
简要总结
This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged > 18 years with CKD
- •Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)
排除标准
- •Non-renal anemia
- •Pregnancy and breast-feeding
- •Uncontrolled hypertension
- •Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
- •Administration of any other study drug within 30 days prior to study enrollment
研究组 & 干预措施
CKD participants treated with Mircera
Participants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 months.
干预措施: Methoxy polyethylene glycol-epoetin beta (Drug)
结局指标
主要结局
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9
时间窗: At Months 7-9
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15
时间窗: At Months 13-15
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18
时间窗: At Months 16-18
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3
时间窗: At Months 1-3
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12
时间窗: At Months 10-12
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline
时间窗: Baseline
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3
时间窗: At Months 1-3
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12
时间窗: At Months 10-12
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15
时间窗: At Months 13-15
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6
时间窗: At Months 4-6
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21
时间窗: At Months 19-21
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline
时间窗: At Baseline
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months
时间窗: After 21 Months up to 36 Months
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6
时间窗: At Months 4-6
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9
时间窗: At Months 7-9
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21
时间窗: At Months 19-21
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months
时间窗: After 21 Months up to 36 Months
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18
时间窗: At Months 16-18
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
次要结局
- Percentage of Participants With Iron Replacement(Up to 36 Months)
- Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L(Up to 36 Months)
- Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta(Baseline)
- Number of Dose Adaptations(Up to 36 Months)
- Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L(Up to 36 Months)
- Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta(Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months)
- Percentage of Participants With Dose 0(Up to 36 Months)