A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 605
- 主要终点
- Median Time to First Cardiovascular Event
研究概览
简要总结
This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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;
- •not receiving renal replacement therapy.
排除标准
- •women who are pregnant or lactating;
- •previous treatment with erythropoietin or other erythropoietic substance;
- •blood transfusion within the last 3 months;
- •need for dialysis expected in the next 6 months;
- •administration of another investigational drug within 30 days preceding study start, or during the study.
研究组 & 干预措施
Early Epoetin Beta Therapy
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
干预措施: epoetin beta [NeoRecormon] (Drug)
Late Epoetin Beta Therapy
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
干预措施: epoetin beta [NeoRecormon] (Drug)
结局指标
主要结局
Median Time to First Cardiovascular Event
时间窗: Up to 4 years
The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. The time to occurrence of a cardiovascular event was determined as the time from randomization until any of the above listed events whichever occurred first. The first event per participant was used for the analysis. Only events confirmed by the Endpoint Committee were considered for analysis.
次要结局
- Median Time to First Hospitalization Due to Cardiovascular Events(Up to 4 years)
- Duration of Hospitalization for Cardiovascular Events(Up to 4 years)
- Median Time to Death Due to All Causes(Up to 4 years)
- Number of Participants Who Died Due to All Causes(Up to 4 years)
- Median Time to First Cardiovascular Intervention(Up to 4 years)
- Mean Change From Baseline in Left Ventricular Volume (LV Volume )(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Median Time to Death Due to Cardiovascular Events(Up to 4 years)
- Number of Participants Who Died Due to Cardiovascular Events(Up to 4 years)
- Total Number of Cardiovascular Intervention(Up to 4 years)
- Mean Change From Baseline in Left Ventricular Mass Index (LVMI)(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire(Baseline, Year 1, and Year 2)
- Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs(Up to 4 years)
- Number of Participants With Marked Laboratory Abnormalities(Baseline, every 3 months up to 4 years)
- Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)(Up to 4 years)
- Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Mean Values of Body Surface Area(Baseline, Year 1, Year 2, Year 3, and Year 4.)
- Mean Values of Echocardiography Parameters(Baseline, Year 1, Year 2, Year 3, and Year 4)