Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)
- Registration Number
- NCT02522975
- Lead Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
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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
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Subjects with chronic kidney disease (CKD) stages* 3 and 4 not yet on dialysis (predialysis)
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Subjects willing to provide a written informed consent
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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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group EPIAO® 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. Reference group EPREX® 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.
- Primary Outcome Measures
Name Time Method Mean absolute change in haemoglobin(Hb) 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."
- Secondary Outcome Measures
Name Time Method Occurence of anti-epoetin antibodies 52 weeks To monitor the occurrence of anti-epoetin antibodies among subjects following at least 52 weeks of therapy.
Mean absolute change in weekly epoetin dosage 24 weeks Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 24 weeks after treatment with EPIAO®/EPREX® in parallel groups (IU/kg/week).
Frequency of adverse events 52 weeks To observe the frequency of adverse events following EPIAO® and EPREX® administration.
Trial Locations
- Locations (8)
Rajavithi hospital
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bangkok, Thailand
Chulalongkorn King Memorial hospital
🇹🇭Bangkok, Thailand
Bamrasnaradura Infectious Disease Institute
🇹🇭Bangkok, Thailand
Phramongkutklao hospital
🇹🇭Bangkok, Thailand
BMA hospital
🇹🇭Bangkok, Thailand
Bhumibol Adulyadej hospital
🇹🇭Bangkok, Thailand
Klongton Hospital
🇹🇭Bangkok, Thailand