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Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study) (BEAT_002)

Primary Purpose

Renal Anemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EPREX®
EPIAO®
Sponsored by
Shenyang Sunshine Pharmaceutical Co., LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Anemia focused on measuring Renal anemia, Haemodialysis, Maintenance phase

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Budgetary Healthcare Institution "Volgogradskiy Regional Center of Urology and Nephrology"
  • 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
  • State Budgetary Healthcare Institution of the Republic of Karelia "V.A. Baranov Republican Hospital"
  • State budgetary healthcare institution "City Clinical Hospital № 1" of Orenburg
  • State Budgetary Educational Institution of Higher Professional Education "North-Western State Medical University named after I.I. Mechnikov " Ministry of Health of 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
  • St- Petersburg state budgetary healthcare institution "City Mariinsky Hospital", department of hemodialysis
  • State budgetary institution "St-Petersburg' scientific-research institution of emergency n.a Dzanelidze)"
  • St-Peterburg State healthcare institution "Municipal hospital of "Elizabethan Hospital
  • Saint-Petersburg State Budgetary Healthcare Institution "City Hospital No. 15"
  • Federal State Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
  • Bamrasnaradura Infectious Disease Institute
  • Bhumibol Adulyadej hospital
  • BMA hospital
  • Chulalongkorn King Memorial hospital
  • Klongton Hospital
  • Phramongkutklao hospital
  • Rajavithi hospital
  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Reference group

Experimental group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean absolute change in haemoglobin level 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).
Mean absolute change in weekly epoetin dosage per kg body weight 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).

Secondary Outcome Measures

Mean absolute change in haemoglobin level 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).
Mean absolute change in weekly epoetin dosage per kg body weight 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
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
Incidence of blood transfusions

Full Information

First Posted
October 26, 2016
Last Updated
November 18, 2022
Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Collaborators
Navitas Life Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02947438
Brief Title
Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)
Acronym
BEAT_002
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 9, 2021 (Actual)
Study Completion Date
October 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Collaborators
Navitas Life Sciences GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Anemia
Keywords
Renal anemia, Haemodialysis, Maintenance phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reference group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EPREX®
Other Intervention Name(s)
Recombinant human erythropoietin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
EPIAO®
Other Intervention Name(s)
Recombinant human erythropoietin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean absolute change in haemoglobin level from baseline to 6 months
Description
Mean absolute change in haemoglobin level from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (g/dl).
Time Frame
from baseline to 6 months
Title
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months
Description
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).
Time Frame
from baseline to 6 months
Secondary Outcome Measure Information:
Title
Mean absolute change in haemoglobin level from baseline to 9 months
Description
Mean absolute change in haemoglobin level from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (g/dl).
Time Frame
from baseline to 9 months
Title
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months
Description
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).
Time Frame
from baseline to 9 months
Title
Proportion of subjects with hemoglobin values are within 10 - 12 g/dl
Description
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)
Time Frame
weeks 32-36
Title
Incidence of blood transfusions
Description
Incidence of blood transfusions
Time Frame
52 weak
Other Pre-specified Outcome Measures:
Title
Incidence and nature of adverse events
Description
Incidence and nature of adverse events
Time Frame
52 weak
Title
Incidence of drug related adverse events
Description
Incidence of drug related adverse events
Time Frame
52 weak
Title
Number of subjects who prematurely withdrew from the study due to AE and SAE
Description
Number of subjects who prematurely withdrew from the study due to AE and SAE
Time Frame
52 weak
Title
Number of subjects with presence of anti-erythropoietin antibodies (anti-EPO Ab)
Description
Number of subjects with presence of anti-erythropoietin antibodies (anti-EPO Ab)
Time Frame
52 weak

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bolong Miao, Doctoral
Organizational Affiliation
Shenyang Sunshine Pharmaceutical Co., LTD.
Official's Role
Study Director
Facility Information:
Facility Name
State Budgetary Healthcare Institution "Volgogradskiy Regional Center of Urology and Nephrology"
City
Volzhskiy
State/Province
Volgogradskaya Region
ZIP/Postal Code
404120
Country
Russian Federation
Facility Name
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
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of the Republic of Karelia "V.A. Baranov Republican Hospital"
City
Moscow
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
State budgetary healthcare institution "City Clinical Hospital № 1" of Orenburg
City
Orenburg
ZIP/Postal Code
460040
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "North-Western State Medical University named after I.I. Mechnikov " Ministry of Health of Russian Federation
City
Saint Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
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
City
Saint Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
St- Petersburg state budgetary healthcare institution "City Mariinsky Hospital", department of hemodialysis
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
State budgetary institution "St-Petersburg' scientific-research institution of emergency n.a Dzanelidze)"
City
Saint Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
St-Peterburg State healthcare institution "Municipal hospital of "Elizabethan Hospital
City
Saint Petersburg
ZIP/Postal Code
195427
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Healthcare Institution "City Hospital No. 15"
City
Saint Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Federal State Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Facility Name
Bamrasnaradura Infectious Disease Institute
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Bhumibol Adulyadej hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
BMA hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chulalongkorn King Memorial hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Klongton Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Phramongkutklao hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Rajavithi hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

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