Renal Anemia
Conditions
Keywords
Renal anemia, Haemodialysis, Maintenance phase
Brief 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.
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 on haemodialysis. A total of 264 subjects will be randomized into two groups in a 1:1 ratio. Treatment arm A will receive EPIAO® 1-3 times a week, intravenously for period of 52 weeks and treatment arm B will receive EPREX, 1-3 times a week, intravenously for period of 52 weeks.
Interventions
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.
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.
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute change in haemoglobin level from baseline to 6 months | from baseline to 6 months | Mean absolute change in haemoglobin level from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (g/dl). |
| Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months | from baseline to 6 months | Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (IU/kg/week). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months | from baseline to 9 months | Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (IU/kg/week). |
| Mean absolute change in haemoglobin level from baseline to 9 months | from baseline to 9 months | Mean absolute change in haemoglobin level from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (g/dl). |
| Proportion of subjects with hemoglobin values are within 10 - 12 g/dl | weeks 32-36 | Proportion of subjects with hemoglobin values are within 10 - 12 g/dl for the last 4 weeks of the period for assessment of treatment of efficacy and safety (weeks 32-36) |
| Incidence of blood transfusions | 52 weak | Incidence of blood transfusions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects who prematurely withdrew from the study due to AE and SAE | 52 weak | Number of subjects who prematurely withdrew from the study due to AE and SAE |
| Number of subjects with presence of anti-erythropoietin antibodies (anti-EPO Ab) | 52 weak | Number of subjects with presence of anti-erythropoietin antibodies (anti-EPO Ab) |
| Incidence of drug related adverse events | 52 weak | Incidence of drug related adverse events |
| Incidence and nature of adverse events | 52 weak | Incidence and nature of adverse events |
Countries
Russia, Thailand
Outcome results
None listed