A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Mean Hb Value at Month 3 Before Inclusion
研究概览
简要总结
An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal clinical environment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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 participants above 18 years of age
- •Pre-dialysis participants with CKD stage 3-4 treated with MIRCERA and continue in the pre-dialysis state for the whole study period
- •Estimated glomerular filteration rate (e-GFR) between 15-60 milliliter per minute (mL/min) (calculated)
排除标准
- •Participants involved in interventional trials
- •Participants with life expectancy less than 1 year
- •Active malignancy
- •Planned living kidney transplant within 6 months.
结局指标
主要结局
Mean Hb Value at Month 3 Before Inclusion
时间窗: Pre-baseline (Month -3)
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion
时间窗: Month 3
Mean Hb Value at Month 6 Before Inclusion
时间窗: Pre-baseline (Month -6)
Mean Hb Value at Month 3 After Inclusion
时间窗: Month 3
Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion
时间窗: Pre-baseline (Month -6)
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion
时间窗: Month 6
Mean Hb Value at Month 6 After Inclusion
时间窗: Month 6
Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline
时间窗: Pre-baseline (Month -6) to Baseline
Hb fluctuation was defined as change in Hb value \>15 gm/L between 2 visits.
Percentage of Participants With Hb Fluctuation From Baseline to Month 12
时间窗: Baseline to Month 12
Hb fluctuation was defined as change in Hb value \>15 gm/L between 2 visits.
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion
时间窗: Month 9
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion
时间窗: Month 12
Mean Hb Value at Month 9 After Inclusion
时间窗: Month 9
Mean Hb Value at Month 12 After Inclusion
时间窗: Month 12
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion
时间窗: Pre-baseline (Month -3)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline
时间窗: Baseline
Mean Hb Value at Baseline
时间窗: Baseline
次要结局
- Percentage of Participants With Change in MIRCERA Treatment(Months 3, 6, 9, and 12)
- Percentage of Participants With Number of MIRCERA Dose Changes(Baseline to Month 12)
- Correlation of Hb Levels With Underlying Disease(Baseline to 12 months)
- Correlation of Hb Levels With Levels of Inflammation(Baseline to 12 months)
- Percentage of Participants With Changes in Iron Supplement(Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12)
- Percentage of Participants With Changes in Immunosuppressive Treatment(Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12)
- Percentage of Participants With Changes in Antihypertensive Treatment(Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12)
- Number of Participants With Different Medication Treatment(Pre-baseline (Month -6) to Month 12)
- Percentage of Participants Who Required Blood Transfusion(Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12)
- Percentage of Participants Who Required Renal Replacement Therapy(Months 3, 6, 9, and 12)