Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)
- Registration Number
- NCT02947438
- Lead Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Brief Summary
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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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: Intravenously injection 1-3 times a week for a period of 52 weeks. 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: Intravenously injection 1-3 times a week for a period of 52 weeks.
- Primary Outcome Measures
Name Time Method Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months 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 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).
- Secondary Outcome Measures
Name Time Method Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months from baseline to 9 months Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (IU/kg/week).
Proportion of subjects with hemoglobin values are within 10 - 12 g/dl weeks 32-36 Proportion of subjects with hemoglobin values are within 10 - 12 g/dl for the last 4 weeks of the period for assessment of treatment of efficacy and safety (weeks 32-36)
Incidence of blood transfusions 52 weak Incidence of blood transfusions
Mean absolute change in haemoglobin level from baseline to 9 months from baseline to 9 months Mean absolute change in haemoglobin level from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (g/dl).
Trial Locations
- Locations (19)
St-Peterburg State healthcare institution "Municipal hospital of "Elizabethan Hospital
🇷🇺Saint Petersburg, Russian Federation
State budgetary institution "St-Petersburg' scientific-research institution of emergency n.a Dzanelidze)"
🇷🇺Saint Petersburg, Russian Federation
Federal State Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
🇷🇺Samara, Russian Federation
Saint-Petersburg State Budgetary Healthcare Institution "City Hospital No. 15"
🇷🇺Saint Petersburg, Russian Federation
Bhumibol Adulyadej hospital
🇹🇭Bangkok, Thailand
Klongton Hospital
🇹🇭Bangkok, Thailand
Rajavithi hospital
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bangkok, Thailand
State Budgetary Educational Institution of Higher Professional Education "North-Western State Medical University named after I.I. Mechnikov " Ministry of Health of Russian Federation
🇷🇺Saint Petersburg, Russian Federation
State Budgetary Healthcare Institution of the Republic of Karelia "V.A. Baranov Republican Hospital"
🇷🇺Moscow, Russian Federation
State Budgetary Healthcare Institution "Volgogradskiy Regional Center of Urology and Nephrology"
🇷🇺Volzhskiy, Volgogradskaya Region, Russian Federation
BMA hospital
🇹🇭Bangkok, Thailand
Chulalongkorn King Memorial hospital
🇹🇭Bangkok, Thailand
State budgetary healthcare institution "City Clinical Hospital № 1" of Orenburg
🇷🇺Orenburg, Russian Federation
St- Petersburg state budgetary healthcare institution "City Mariinsky Hospital", department of hemodialysis
🇷🇺Saint Petersburg, Russian Federation
State budgetary healthcare institution of Moscow region "Moscow Regional Scientific Research and Clinical Institute named after M.F.Vladimirsky", Department of Transplantation, nephrology and surgical hemocorrection
🇷🇺Moscow, Russian Federation
The Federal State Budgetary Institute "The Nikiforov Russian Center of Emergency and Radiation Medicine" of the Ministry of Russian Federation for Civil Defense, Emergencies and Elimination of Consequences of Natural Disasters
🇷🇺Saint Petersburg, Russian Federation
Bamrasnaradura Infectious Disease Institute
🇹🇭Bangkok, Thailand
Phramongkutklao hospital
🇹🇭Bangkok, Thailand