- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02947438
Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study) (BEAT_002)
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Moscow, Russian Federation, 129110
- 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
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Moscow, Russian Federation, 185019
- State Budgetary Healthcare Institution of the Republic of Karelia "V.A. Baranov Republican Hospital"
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Orenburg, Russian Federation, 460040
- State budgetary healthcare institution "City Clinical Hospital № 1" of Orenburg
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Saint Petersburg, Russian Federation, 191015
- State Budgetary Educational Institution of Higher Professional Education "North-Western State Medical University named after I.I. Mechnikov " Ministry of Health of Russian Federation
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Saint Petersburg, Russian Federation, 191015
- 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
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Saint Petersburg, Russian Federation, 191104
- St- Petersburg state budgetary healthcare institution "City Mariinsky Hospital", department of hemodialysis
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Saint Petersburg, Russian Federation, 192242
- State budgetary institution "St-Petersburg' scientific-research institution of emergency n.a Dzanelidze)"
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Saint Petersburg, Russian Federation, 195427
- St-Peterburg State healthcare institution "Municipal hospital of "Elizabethan Hospital
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Saint Petersburg, Russian Federation, 198205
- Saint-Petersburg State Budgetary Healthcare Institution "City Hospital No. 15"
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Samara, Russian Federation, 443099
- Federal State Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
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Volgogradskaya Region
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Volzhskiy, Volgogradskaya Region, Russian Federation, 404120
- State Budgetary Healthcare Institution "Volgogradskiy Regional Center of Urology and Nephrology"
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Bangkok, Thailand, 10700
- Siriraj Hospital
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Bangkok, Thailand, 10700
- Bamrasnaradura Infectious Disease Institute
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Bangkok, Thailand, 10700
- Bhumibol Adulyadej Hospital
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Bangkok, Thailand, 10700
- BMA hospital
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Bangkok, Thailand, 10700
- Chulalongkorn King Memorial hospital
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Bangkok, Thailand, 10700
- Klongton Hospital
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Bangkok, Thailand, 10700
- Phramongkutklao Hospital
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Bangkok, Thailand, 10700
- Rajavithi Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: 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. |
Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease. Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000.
Other Names:
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EXPERIMENTAL: 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. |
Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease. Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean absolute change in haemoglobin level from baseline to 6 months
Time Frame: from baseline to 6 months
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Mean absolute change in haemoglobin level from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (g/dl).
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from baseline to 6 months
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Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months
Time Frame: from baseline to 6 months
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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).
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from baseline to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean absolute change in haemoglobin level from baseline to 9 months
Time Frame: from baseline to 9 months
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Mean absolute change in haemoglobin level from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (g/dl).
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from baseline to 9 months
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Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months
Time Frame: from baseline to 9 months
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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).
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from baseline to 9 months
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Proportion of subjects with hemoglobin values are within 10 - 12 g/dl
Time Frame: weeks 32-36
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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)
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weeks 32-36
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Incidence of blood transfusions
Time Frame: 52 weak
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Incidence of blood transfusions
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52 weak
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and nature of adverse events
Time Frame: 52 weak
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Incidence and nature of adverse events
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52 weak
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Incidence of drug related adverse events
Time Frame: 52 weak
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Incidence of drug related adverse events
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52 weak
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Number of subjects who prematurely withdrew from the study due to AE and SAE
Time Frame: 52 weak
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Number of subjects who prematurely withdrew from the study due to AE and SAE
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52 weak
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Number of subjects with presence of anti-erythropoietin antibodies (anti-EPO Ab)
Time Frame: 52 weak
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Number of subjects with presence of anti-erythropoietin antibodies (anti-EPO Ab)
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52 weak
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Bolong Miao, Doctoral, Shenyang Sunshine Pharmaceutical Co., LTD.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSS_EP_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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