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

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ClinicalTrials.gov Identifier: NCT02522975
Recruitment Status : Terminated
First Posted : August 14, 2015
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Navitas Life Sciences GmbH
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Renal Anaemia Drug: EPIAO® Drug: EPREX® Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2015
Actual Primary Completion Date : June 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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

Drug: EPREX®

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 Name: Recombinant human erythropoietin

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

Drug: EPIAO®

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 Name: Recombinant human erythropoietin




Primary Outcome Measures :
  1. Mean absolute change in haemoglobin(Hb) [ Time Frame: 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 :
  1. Mean absolute change in weekly epoetin dosage [ Time Frame: 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).

  2. Frequency of adverse events [ Time Frame: 52 weeks ]
    To observe the frequency of adverse events following EPIAO® and EPREX® administration.

  3. Occurence of anti-epoetin antibodies [ Time Frame: 52 weeks ]
    To monitor the occurrence of anti-epoetin antibodies among subjects following at least 52 weeks of therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522975


Locations
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Thailand
Bamrasnaradura Infectious Disease Institute
Bangkok, Thailand, 10700
Bhumibol Adulyadej hospital
Bangkok, Thailand, 10700
BMA hospital
Bangkok, Thailand, 10700
Chulalongkorn King Memorial hospital
Bangkok, Thailand, 10700
Klongton Hospital
Bangkok, Thailand, 10700
Phramongkutklao hospital
Bangkok, Thailand, 10700
Rajavithi hospital
Bangkok, Thailand, 10700
Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.
Navitas Life Sciences GmbH
Investigators
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Study Director: BOLONG MIAO, Ph.D Shenyang Sunshine Pharmaceutical Co., LTD.
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Responsible Party: Shenyang Sunshine Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT02522975    
Other Study ID Numbers: SSS_EP_001
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Keywords provided by Shenyang Sunshine Pharmaceutical Co., LTD.:
biosimilar epoetin
efficacy
safety
immunogenicity
renal anaemia
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics