A Prospective, Randomized, Double Blind, Parallel Group Study to Establish the Therapeutic Equivalence of EPIAO® With the Standard Treatment EPREX® in Subjects With Chronic Kidney Disease (CKD) Related Anaemia Not Yet on Dialysis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 8
- 主要终点
- Mean absolute change in haemoglobin(Hb)
研究概览
简要总结
This study is aimed to comprehensively establish the biosimilarity/bioquivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy,safety and immunogenicity.The targeted population is anaemia patients with chronic renal disease who are naive to epoetin treatment and not yet 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 not yet on dialysis (pre-dialysis). A total of 96 subjects will be randomized into two groups in a 1:1ratio. Treatment arm A will receive EPIAO® once a week, subcutaneously for period of 52 weeks and treatment arm B will receive EPREX, weight once a week, subcutaneously 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 renal anaemia (haemoglobin 7.5 g/dl to 10 g/dl)
- •Subjects who are treatment naïve to epoetin
- •Subjects with chronic kidney disease (CKD) stages* 3 and 4 not yet on dialysis (predialysis)
- •Subjects willing to provide a written informed consent
- •Subjects with serum ferritin ≥ 100 μg/L and/or transferrin saturation ≥ 20%
- •CKD staging will be based on the five-stage system for classification of CKD based on KDIGO guidelines.
排除标准
- •Subjects with anaemia due to other reasons (that is not renal anaemia)
- •Subjects on dialysis
- •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 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 (thrombocytopenia, neutropenia, or hemolysis)
- •Subjects with hyperparathyroidism (intact parathyroid hormone > 1000 pg/ml)
- •Subjects with severe liver dysfunction
- •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 Hepatitis B virus (HbsAg), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV) and syphilis
- •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:subcutaneously injection once a week for a period of 52 weeks. The initial dose of EPREX® will be 60 IU/kg body weight.
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:subcutaneously injection once a week for a period of 52 weeks. The initial dose of EPIAO® will be 60 IU/kg body weight.
干预措施: EPIAO® (Drug)
结局指标
主要结局
Mean absolute change in haemoglobin(Hb)
时间窗: 24 weeks
Mean absolute change in haemoglobin(Hb) level from baseline to 24 weeks after treatment with EPIAO®/EPREX® in parallel groups (g/dl),respectively."
次要结局
- Occurence of anti-epoetin antibodies(52 weeks)
- Mean absolute change in weekly epoetin dosage(24 weeks)
- Frequency of adverse events(52 weeks)