Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)

NCT02522975 | Terminated Phase 4 DMC

• 1 other identifier: SSS_EP_001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 8

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.

Conditions

Renal Anaemia

Keywords

biosimilar epoetin; efficacy; safety; immunogenicity; renal anaemia

Outcome Measures

Primary Outcomes (1)

• 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."

  24 weeks

Secondary Outcomes (3)

• Mean absolute change in weekly epoetin dosage

  24 weeks

• Frequency of adverse events

  52 weeks

• Occurence of anti-epoetin antibodies

  52 weeks

Study Arms (2)

Reference group

ACTIVE COMPARATOR

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®

Experimental group

EXPERIMENTAL

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®

Interventions

EPIAO® DRUG

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.

Also known as: Recombinant human erythropoietin

Experimental group

EPREX® DRUG

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.

Also known as: Recombinant human erythropoietin

Reference group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead
• Navitas Life Sciences GmbH: collaborator

Study Sites (8)

Bamrasnaradura Infectious Disease Institute

Bangkok, 10700, Thailand

Location

Bhumibol Adulyadej hospital

Bangkok, 10700, Thailand

Location

BMA hospital

Bangkok, 10700, Thailand

Location

Chulalongkorn King Memorial hospital

Bangkok, 10700, Thailand

Location

Klongton Hospital

Bangkok, 10700, Thailand

Location

Phramongkutklao hospital

Bangkok, 10700, Thailand

Location

Rajavithi hospital

Bangkok, 10700, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

Epoetin Alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• BOLONG MIAO, Ph.D

  Shenyang Sunshine Pharmaceutical Co., LTD.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 14, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

TH (8)