Efficacy of Methoxy Poly-Ethylene Glycol Epoetin Beta (C.E.R.A.) for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV, Not on Dialysis, Treated According to Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- Mean Weight of Participants at Baseline (Week 0)
研究概览
简要总结
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18 to 65 years of age, inclusive
- •Patients with stage III-IV chronic kidney disease not on dialysis
- •Erythropoiesis stimulating agent (ESA) naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
- •Adequate iron status as judged by the treating physician
排除标准
- •Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •Clinically significant concomitant disease or disorder as defined by protocol
- •Clinical suspicion of pure red cell aplasia (PRCA)
- •Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
- •Transfusion of red blood cells in the previous 2 months
- •Pregnant women
- •Contraindications for Mircera according to local prescribing information or as judged by the investigator
研究组 & 干预措施
C.E.R.A.
Participants with chronic renal anemia Stage III-IV, not on dialysis, will be administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) according to routine clinical practice and will be followed up for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment will be at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label are - For correction of anemia: 0.6 microgram per kilogram (mcg/kg) of C.E.R.A. once every two weeks, and for Maintenance of hemoglobin (Hb) levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
干预措施: C.E.R.A. (Drug)
结局指标
主要结局
Mean Weight of Participants at Baseline (Week 0)
时间窗: At Baseline (Week 0)
The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.
Number of Participants With Co-morbidities at Baseline (Week 0)
时间窗: At Baseline (Week 0)
Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.
Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)
时间窗: Up to Week 24
Correction of anemia was evaluated in participants with Hb \< 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.
Mean Height of Participants at Baseline (Week 0)
时间窗: At Baseline (Week 0)
The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.
Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value
时间窗: Up to Week 24
Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.
次要结局
- Mean Dose of C.E.R.A. Administered(Up to Week 24)
- Number of Doses of C.E.R.A. Administered by Different Routes(Up to Week 24)
- Number of Participants Who Received Concomitant Treatment for Anemia(Up to Week 24)
- Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)(Up to Week 24)
- Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study(Up to Week 24)
- Number of Participants With Adverse Events and Serious Adverse Events(Up to Week 24)