Comparative Study to Evaluate the Effect of the Altitude on Dosage Requirements of Methoxy Polyethylene Glycol-Epoetin Beta to Correct Hemoglobin Levels in Chronic Renal Anemia in Pre-Dialysis and Dialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 7
- 主要终点
- Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
研究概览
简要总结
This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 participants, >/= 18 years of age
- •Chronic kidney disease stage III-IV or V
- •Probable start of dialysis within 18 months (pre-dialysis group)
- •Hemodialysis or peritoneal dialysis in a stable regimen for at least 3 months (dialysis group)
- •Adequate iron status
- •Females of childbearing potential must agree to use two effective methods of contraception during the study and for at least 2 months following the last dose of study drug
排除标准
- •Failing renal allograft in place
- •Acute or chronic bleeding within 8 weeks prior to screening
- •Transfusion of red blood cells within 8 weeks prior to screening
- •Poorly controlled hypertension, defined as hypertension that needs hospitalization to obtain control
- •History of seizures, hemoglobinopathies and/or severe liver disease
- •Active malignant disease, except for non-melanoma skin cancer
- •Immunosuppressive therapy in the 12 weeks prior to screening
- •Treatment with any other investigational agent or participation in a clinical trial within 28 days prior to enrolment
- •Known hypersensitivity to Mircera (methoxy polyethylene glycol-epoetin beta) or any of its excipients
- •Pregnant or lactating women
研究组 & 干预措施
Dialysis, sea level
Participants received 50-250 mcg SC according to local label.
干预措施: Methoxy polyethylene glycol-epoetin beta (Drug)
Pre-dialysis, sea level
Participants received 50-250 mcg SC according to local label.
干预措施: Methoxy polyethylene glycol-epoetin beta (Drug)
Pre-dialysis, >1800 meters
Participants received 50-250 mcg SC according to local label.
干预措施: Methoxy polyethylene glycol-epoetin beta (Drug)
Dialysis, >1800 meters
Participants received 50-250 mcg SC according to local label.
干预措施: Methoxy polyethylene glycol-epoetin beta (Drug)
结局指标
主要结局
Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
时间窗: Up to approximately 20 months
次要结局
- Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment(3 and 6 months)
- Percentage of Participants Requiring Dose Adjustments(Up to approximately 20 months)
- Change in Hemoglobin Concentration(From baseline to 6 months)
- Percentage of Participants With Adverse Events(Up to approximately 20 months)
- Incidence of Red Blood Cell Transfusions(Up to approximately 20 months)