Erythropoietins in Management of Anemia of End Stage Renal Disease: A Prospective Study From Qatar.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Comparison of efficacy among erythropoetin stimulating agents.
研究概览
简要总结
* Background: Despite extensive use, to the best of our knowledge, no trial has simultaneously compared the three currently used erythropoietin stimulating agents (ESAs) in a prospective manner, in treatment of anemia of end stage renal disease (ESRD) patients.
* Patients and Methods: All haemodialysis patients in Qatar who were treated with short acting Epoetin alfa or beta were screened. Eligible patients were randomized, either to continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. All groups were assessed at the end of the study for safety and efficacy parameters.
详细描述
- Objectives of the study
- Primary Objective To evaluate efficacy of continuous erythropoietin receptor activator (C.E.R.A.) and Darbepoetin Alfa, to maintain Hemoglobin level - within the target recommended range - among ESRD patients, in direct comparison to currently available ESA (Epoetin alfa and beta).
- Secondary Objective To compare the safety profile of the three groups (Epoetin, Darbepoetin alpha, C.E.R.A.) by the prevalence of associated morbidity and mortality.
- Patients and Methods
- Study Subjects All haemodialysis patients of the main dialysis centers in Qatar (Doha, Alkhour and Alwakra) were screened.
- Study Design This is a prospective, randomized, comparative, open label study. The study has passed through three phases; the first phase was screening period for 4 weeks, the 2nd phase was titration period for 12 weeks and the third phase was evaluation period for 24 weeks.
All patients have entered a 4-week screening/baseline period during which they continued to receive their previous Epoetin beta or alfa treatment.
Eligible patients were then randomly assigned (1:1:1), either to continue on the previous same dose and route of administration of Epoetin alpha or beta (Epoetin group), or to receive Darbepoetin alfa (Aranesp ® Amgen) every week or 2weeks (Darbepoetin group) or methoxy polyethylene glycol-epoetin beta (Mircera ® Roche ,F. Hoffmann-La Roche, Basel, Switzerland) once monthly (C.E.R.A. group).
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
- •Aged ≥18 years
- •have stable chronic renal anemia (with hemoglobin range of 10-12 g/dL) and on regular haemodialysis 3 x week with urea reduction ratio greater or equal to 65% or KT/V ( K - dialyzer clearance of urea, t - dialysis time, V - volume of distribution of urea, approximately equal to patient's total body water) greater or equal to 1.
- •Patients must have received haemodialysis three times weekly for ≥12 weeks before screening and during the 4-week screening/baseline period.
- •Eligible patients must have stable hemoglobin concentrations (stable is defined as ≤25% change in weekly dose of ESA over 8 weeks).
- •Recruited patients must have undergone continuous maintenance intravenous conventional Epoetin alpha or beta therapy for ≥8 weeks before screening and during the screening/baseline.
- •Patients should have adequate iron status, defined as serum ferritin ≥100 μg/L and transferrin saturation ≥20%.
排除标准
- •New York Heart Association (NYHA) class III or IV congestive heart failure
- •Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure
- •105 mmHg or systolic BP≥ 160 mmHg during the screening period)
- •Evidence of uncontrolled hyperparathyroidism (defined as parathyroid hormone level >1000 pg/ml with no response to conventional treatment of hyperparathyroidism according to Kidney Disease Outcomes Quality Initiative (KDOQI) guide line during the 12 months prior to baseline)
- •Treatment for grand mal epilepsy
- •Haematological, inflammatory or infectious conditions that might interfere with the erythropoietin response
- •Received red blood cell transfusions within 12 weeks before screening or during the screening/baseline period.
- •reactive protein >30 mg/L
- •The likelihood of early withdrawal; or life expectancy of <12 months
- •Poor compliance with dialysis treatment, evidenced by >2 missed treatment monthly over the previous 3 months
- •Refuse to be involved in the study.
研究组 & 干预措施
Epoetin alpha or beta (Epoetin group)
Patients in that arm were continued on the previous same dose and route of administration of Epoetin alpha/ beta (Epoetin group).
干预措施: Epoetin alpha or beta (Epoetin group) (Drug)
Darbepoetin alpha
subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol.
干预措施: Darbepoetin alfa (Drug)
Methoxy polyethylene glycol-epoetin beta
Patients in that arm received Intravenous Methoxy polyethylene glycol-epoetin beta monthly.
干预措施: Methoxy polyethylene glycol-epoetin beta (Drug)
结局指标
主要结局
Comparison of efficacy among erythropoetin stimulating agents.
时间窗: Every week up to 36 weeks
To evaluate efficacy of continuous erythropoietin receptor activator (C.E.R.A.) and Darbepoetin Alfa, to maintain Hemoglobin level - within the target recommended range - among ESRD patients, in direct comparison to currently available ESA (Epoetin alfa and beta). by measuring percentage of cases with mean Hemoglobin concentration between 11-12 gm/dl and measuring mean monthly hemoglobin concentrations.
次要结局
- comparison between safety profile of different types of erythropoetin simulating agents.(Up 36 weeks)