Renal Anaemia
Conditions
Keywords
biosimilar epoetin, efficacy, safety, immunogenicity, renal anaemia
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.
Interventions
DRUGEPIAO®
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.
DRUGEPREX®
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.
Sponsors
Navitas Life Sciences GmbH
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute change in haemoglobin(Hb) | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute change in weekly epoetin dosage | 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). |
| Frequency of adverse events | 52 weeks | To observe the frequency of adverse events following EPIAO® and EPREX® administration. |
| Occurence of anti-epoetin antibodies | 52 weeks | To monitor the occurrence of anti-epoetin antibodies among subjects following at least 52 weeks of therapy. |
Countries
Thailand
Outcome results
None listed