search
Back to results

Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study) (BEAT_001)

Primary Purpose

Renal Anaemia

Status
Terminated
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
EPIAO®
EPREX®
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 Anaemia focused on measuring biosimilar epoetin, efficacy, safety, immunogenicity, renal anaemia

Eligibility Criteria

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

Inclusion Criteria:

  1. Male and female subjects between the age of 18 to 75 years
  2. Subjects with renal anaemia (haemoglobin 7.5 g/dl to 10 g/dl)
  3. Subjects who are treatment naïve to epoetin
  4. Subjects with chronic kidney disease (CKD) stages* 3 and 4 not yet on dialysis (predialysis)
  5. Subjects willing to provide a written informed consent

  6. 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.

Exclusion Criteria:

  1. Subjects with anaemia due to other reasons (that is not renal anaemia)
  2. Subjects on dialysis
  3. Subjects who have undergone blood transfusion within the last 3 months
  4. Subjects with major complication such as severe/chronic infections or bleeding, or aluminum toxicity
  5. Subjects with suspected or known PRCA
  6. Subjects with a history of aplastic anaemia
  7. 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)
  8. Subjects with known hypersensitivity to any of the ingredients of the investigational products, the mammalian cell-derived product or human albumin products
  9. Subjects with history of seizure disorder
  10. Subjects with hematological disorder (thrombocytopenia, neutropenia, or hemolysis)
  11. Subjects with hyperparathyroidism (intact parathyroid hormone > 1000 pg/ml)
  12. Subjects with severe liver dysfunction
  13. Subjects with congestive heart failure and/or angina (NYHA class III and IV)
  14. Subjects with myocardial infarction or stroke in the preceding 6 months of screening
  15. Subjects with active malignancy in the previous 5 years
  16. Subjects with gastrointestinal bleeding in the past 6 months
  17. Subjects with immunosuppressive therapy in the previous 3 months
  18. Subjects with Hepatitis B virus (HbsAg), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV) and syphilis
  19. 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
  20. Subjects participating in trials involving erythropoietin in the past 6 months before screening
  21. Subjects currently participating or participation in an investigational study within 30 days prior screening

Sites / Locations

  • 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:subcutaneously injection once a week for a period of 52 weeks. The initial dose of EPREX® will be 60 IU/kg body weight.

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.

Outcomes

Primary Outcome Measures

Mean absolute change in haemoglobin(Hb)
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

Mean absolute change in weekly epoetin dosage
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
To observe the frequency of adverse events following EPIAO® and EPREX® administration.
Occurence of anti-epoetin antibodies
To monitor the occurrence of anti-epoetin antibodies among subjects following at least 52 weeks of therapy.

Full Information

First Posted
August 10, 2015
Last Updated
October 19, 2020
Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Collaborators
Navitas Life Sciences GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT02522975
Brief Title
Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)
Acronym
BEAT_001
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
August 2019 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Anaemia
Keywords
biosimilar epoetin, efficacy, safety, immunogenicity, renal anaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (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:subcutaneously injection once a week for a period of 52 weeks. The initial dose of EPREX® will be 60 IU/kg body weight.
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:subcutaneously injection once a week for a period of 52 weeks. The initial dose of EPIAO® will be 60 IU/kg body weight.
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.
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.
Primary Outcome Measure Information:
Title
Mean absolute change in haemoglobin(Hb)
Description
Mean absolute change in haemoglobin(Hb) level from baseline to 24 weeks after treatment with EPIAO®/EPREX® in parallel groups (g/dl),respectively."
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mean absolute change in weekly epoetin dosage
Description
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).
Time Frame
24 weeks
Title
Frequency of adverse events
Description
To observe the frequency of adverse events following EPIAO® and EPREX® administration.
Time Frame
52 weeks
Title
Occurence of anti-epoetin antibodies
Description
To monitor the occurrence of anti-epoetin antibodies among subjects following at least 52 weeks of therapy.
Time Frame
52 weeks

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 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BOLONG MIAO, Ph.D
Organizational Affiliation
Shenyang Sunshine Pharmaceutical Co., LTD.
Official's Role
Study Director
Facility Information:
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

Learn more about this trial

Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)

We'll reach out to this number within 24 hrs