Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)
Information source: Shenyang Sunshine Pharmaceutical Co., LTD.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Anaemia
Intervention: EPIAO® (Drug); EPREX® (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Shenyang Sunshine Pharmaceutical Co., LTD. Official(s) and/or principal investigator(s): BOLONG MIAO, Ph.D, Study Director, Affiliation: Shenyang Sunshine Pharmaceutical Co., LTD.
Overall contact: BOLONG MIAO, Ph.D, Phone: +8624 25386082, Email: miaobolong@3sbio.com.cn
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean absolute change in haemoglobin(Hb)
Secondary outcome: Mean absolute change in weekly epoetin dosageFrequency of adverse events Occurence of anti-epoetin antibodies
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
BOLONG MIAO, Ph.D, Phone: +8624 25386082, Email: miaobolong@3sbio.com.cn Additional Information
Starting date: August 2015
Last updated: August 12, 2015
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