Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
• Collaborators: Ecron Acunova GmbH; Navitas Life Sciences GmbH
• Treatments: Epoetin Alfa

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