NCT02506868已完成3 期
Multicenter Double-blind Randomized Parallel Comparative Study of Efficacy and Safety of BCD-066 (CJSC BIOCAD, Russia) and Aranesp (Amgen Europe B.V., Netherlands) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 196
- 试验地点
- 30
- 主要终点
- Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
研究概览
简要总结
The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.
详细描述
In this study CKD patients on dialysis previously treated by short-acting epoetins will switch to one of darbepoetin alfa products - BCD-066 (experimental arm) or Aranesp (active comparator) to maintain previously achieved target level of hemoglobin (100-120 g/l).
Patients will be treated for 52 weeks. IV iron supplementation will be provided to maintain serum ferritin level above 500 µg/l according to KDIGO Anemia Guidelines (2012).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age between 18 and 75 years
- •End-stage kidney disease
- •Need for dialysis for at least 3 months before enrollment
- •Need for at least 12 hours on standard dialysis procedure weekly
- •Regular rHuEpo (epoetin alfa, epoetin beta, darbepoetin alfa) administration 1, 2 or 3 times a week (stable dose, stable frequency) for at least 3 months before enrollment
- •Target hemoglobin level (100-120 g/l) for at least 3 months before enrollment
- •Effective dialysis (Kt/v≥1,2)
- •TSAT ≥20%, Serum ferritin >200 ng/ml
- •Patients and their sexual partners with childbearing potential must implement reliable contraceptive measures during all the study treatment, starting 4 weeks prior to the administration of the first dose of investigational product until 4 weeks after the last dose of investigational product. This requirement does not apply to participants who have undergone surgical sterilization. Reliable contraceptive measures include two methods of contraception, including one barrier method
- •Patients should be able to follow the Protocol procedures (according to Investigator's assessment)
排除标准
- •Any other causes of anemia except for renal anemia, including folate and B12 deficiency, chronic blood loss, aluminium intoxication, sickle-cell anemia, chronic disease anemia (CRP above 20 mg/l), refractory anemia with blast cells in peripheral blood
- •Lupus nephritis of kidney disease due to systemic vasculitis
- •Platelet count below 100х10^9 cells/l
- •Hemoglobin above 120 g/l or below 100 g/l
- •Scheduled kidney transplant during study participation period
- •Binding/neutralizing antibodies against erythropoetin/darbepoetin
- •History of severe allergic reactions
- •Vaccination less than 8 weeks before enrollment
- •Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis
- •HIV infection, active HBV, HCV
- •ALT, AST level above 3x ULN
- •Bone marrow fibrosis
- •Congestive heart failure (Grade IV NYHA)
- •Resistant arterial hypertension
- •Unstable angina
- •Hemoglobinopathy, MDS, hematologic malignancy
- •Severe secondary hyperparathyroidism (PTH > 9x ULN)
- •GI bleeding history
- •Thrombotic events history (myocardial infarction, stroke, TIA, DVT, PATE) less than 6 months before enrollment
- •Acute hemolysis history
- •Seizures, including epilepsy
- •Major surgery in less than 1 month before enrollment
- •Blood transfusions in less than 3 months before enrollment
- •Acute inflammatory diseases or exacerbations of chronic inflammation including septic of aseptic inflammation foci
- •Severe psychiatric disorders
- •History of malignancy, excluding appropriately treated basal cell carcinoma or cervical carcinoma in situ
- •Alcohol or drug abuse
- •Hypersensitivity to darbepoetin alfa of any components of study drugs
- •Simultaneous participation in other trials or in less than 3 months before enrollment
- •Pregnancy of breast-feeding
研究组 & 干预措施
BCD-066
Experimental
Patients in this arm will receive weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks
干预措施: Darbepoetin alfa (Drug)
Aranesp
Active Comparator
Patients in this arm will receive weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
时间窗: Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 24
次要结局
- Number or Percentage of Patients Who Have Target Hemoglobin Concentration During Evaluation Period(Weeks 21 to 24)
- Hemoglobin Level Dynamics(Weeks 1 to 24)
- Number of Participants With Grade 3-4 AE/SAE(Weeks 1 to 52)
- Number or Percentage of Patients With Hemoglobin Level Between 90 and 100 g/l(Weeks 21 to 24)
- Mean Darbepoetin Alfa Dose During Evaluation Period(Week 21 to Week 24)
- Number or Percentage of Patients With Need for 'Dose Titration' at the Beginning of the Study(Weeks 1 to 20)
- Mean Darbepoetin Alfa Dose During the Whole Study(Week 24)
- Number of Patients With AE/SAE (AE/SAE Incidence)(Weeks 1 to 52)
- Number or Percentage of Patients With Need for Blood Transfusions(Weeks 1 to 24)
- Mean Hemoglobin Level During Evaluation Period(Week 24)
- Mean Hemoglobin Level During the Whole Study (24 Week)(Week 24)
- Number of Participants Who Withdrew From Study Due to AE/SAE(Weeks 1 to 52)
- Mean Hematocrit Level During the Whole Study(Week 24)
- Number of Participants With Arterial and Venous Thrombotic Events(Weeks 1 to 52)
- Number or Percentage of Patients With Binding and/or Neutralizing Antibodies Against Darbepoetin Alfa(Weeks 1 to 52)
研究者
研究点 (30)
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