A Prospective, Randomized, Double Blind, Parallel Group Study to Evaluate a 1:1 Dose Conversion From EPREX to EPIAO in Term of Clinical Efficacy and Safety in Subjects With End-Stage Renal Disease on Haemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 19
- 主要终点
- Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months
研究概览
简要总结
This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy, safety and immunogenicity. The targeted population is anaemia patients with end-stage chronic renal disease who previously received epoetin treatment and on haemodialysis.
详细描述
This is a prospective, randomized, double blind, parallel group two arm study to establish the therapeutic equivalence, safety and tolerability of EPIAO® as compared to EPREX® in the treatment of CKD related anaemia in subjects who are on haemodialysis. A total of 264 subjects will be randomized into two groups in a 1:1 ratio. Treatment arm A will receive EPIAO® 1-3 times a week, intravenously for period of 52 weeks and treatment arm B will receive EPREX, 1-3 times a week, intravenously for period of 52 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between the age of 18 to 75 years
- •Subjects with end stage renal disease (CKD stage 5) on hemodialysis and on epoetin treatment for at least 3 months prior to screening
- •Subjects with haemoglobin between 10 g/dl to 12 g/dl
- •Subjects who are on clinically stable haemodialysis (defined as no clinically relevant changes of dialysis regimen and/or dialyzer) for at least 3 months prior to screening
- •Subjects willing to provide a written informed consent
- •Subjects with serum ferritin ≥ 200 μg/L and/or transferrin saturation ≥ 20%
- •Subjects with a life expectancy of more than at least study period in clinical judgment of the investigator
排除标准
- •Subjects with anaemia due to other reasons (that is not renal anaemia)
- •Subjects who have undergone blood transfusion within the last 3 months
- •Subjects with major complication such as severe/chronic infections or bleeding or aluminum toxicity
- •Subjects with suspected or known pure red cell aplasia (PRCA)
- •Subjects with a history of aplastic anaemia
- •Subjects with uncontrolled diabetes (fasting blood glucose > 240 mg/dl) or uncontrolled hypertension (systolic blood pressure > 180 mm Hg, diastolic blood pressure > 110 mm Hg)
- •Subjects with known hypersensitivity to any of the ingredients of the investigational products, the mammalian cell-derived product or human albumin products
- •Subjects with history of seizure disorder
- •Subjects with hematological disorder
- •Subjects with hyperparathyroidism
- •Subjects with congestive heart failure and/or angina (NYHA class III and IV)
- •Subjects with myocardial infarction or stroke in the preceding 6 months of screening
- •Subjects with active malignancy in the previous 5 years
- •Subjects with gastrointestinal bleeding in the past 6 months
- •Subjects with immunosuppressive therapy in the previous 3 months
- •Subjects with active hepatitis B virus (HBsAg) (positive for HBsAg and IgM anti-HBc) and hepatitis C virus (HCV) (positive for Anti-HCV antibody) and human immunodeficiency virus (HIV)
- •Female subjects who are pregnant, breast-feeding, planning to be pregnant during the study, or women of child-bearing potential (any woman who is not surgically sterile i.e. bilateral tubal ligation, total hysterectomy or < 2 years post menopause) not using a reliable method of double contraception (e.g. condom plus diaphragm, condom or diaphragm plus spermicidal gel/foam, tubal ligation, or stable dose of hormonal contraception) throughout the study period
- •Subjects participating in trials involving erythropoietin in the past 6 months before screening.Subjects currently participating or participation in an investigational study within 30 days prior screening
研究组 & 干预措施
Reference group
Generic name: recombinant human erythropoetin injection which is indicated for the treatment of anaemia caused by chronic renal disease.
Dosage form:Injection Strength: 2000IU, 3000IU, 4000IU
Frequency and Dosage: Intravenously injection 1-3 times a week for a period of 52 weeks.
干预措施: EPREX® (Drug)
Experimental group
Generic name: recombinant human erythropoetin injection which is indicated for the treatment of anaemia caused by chronic renal disease.
Dosage form: Injection Strength: 2000IU, 3000IU, 4000IU
Frequency and Dosage: Intravenously injection 1-3 times a week for a period of 52 weeks.
干预措施: EPIAO® (Drug)
结局指标
主要结局
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months
时间窗: from baseline to 6 months
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (IU/kg/week).
Mean absolute change in haemoglobin level from baseline to 6 months
时间窗: from baseline to 6 months
Mean absolute change in haemoglobin level from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (g/dl).
次要结局
- Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months(from baseline to 9 months)
- Proportion of subjects with hemoglobin values are within 10 - 12 g/dl(weeks 32-36)
- Incidence of blood transfusions(52 weak)
- Mean absolute change in haemoglobin level from baseline to 9 months(from baseline to 9 months)