Renal Anaemia Clinical Trial
— BEAT_001Official 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
| NCT number | NCT02522975 |
| Other study ID # | SSS_EP_001 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | August 2015 |
| Est. completion date | August 2019 |
| Verified date | October 2020 |
| Source | Shenyang Sunshine Pharmaceutical Co., LTD. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 16 |
| Est. completion date | August 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Bamrasnaradura Infectious Disease Institute | Bangkok | |
| Thailand | Bhumibol Adulyadej hospital | Bangkok | |
| Thailand | BMA hospital | Bangkok | |
| Thailand | Chulalongkorn King Memorial hospital | Bangkok | |
| Thailand | Klongton Hospital | Bangkok | |
| Thailand | Phramongkutklao hospital | Bangkok | |
| Thailand | Rajavithi hospital | Bangkok | |
| Thailand | Siriraj Hospital | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Shenyang Sunshine Pharmaceutical Co., LTD. | Navitas Life Sciences GmbH |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Mean absolute change in weekly epoetin dosage | 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). | 24 weeks | |
| Secondary | Frequency of adverse events | To observe the frequency of adverse events following EPIAO® and EPREX® administration. | 52 weeks | |
| Secondary | Occurence of anti-epoetin antibodies | To monitor the occurrence of anti-epoetin antibodies among subjects following at least 52 weeks of therapy. | 52 weeks |