NCT00701714终止3 期
Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sandoz
- 入组人数
- 337
- 试验地点
- 116
- 主要终点
- Change in Hemoglobin Level
研究概览
简要总结
This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia.
Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known chronic renal insufficiency of at least 4 weeks duration; CKD stage at least 3 or higher
- •Male and female patients, age: >=18
- •Patients who are naïve to ESA treatment or previously ESA treated after 3 months of ESA-free period (i.v. or s.c.)
- •Patients with symptomatic anemia, defined as Hb level below 11.0 g/dL and not lower than or equal to 7.5 g/dL on at least 2 visits during the screening period
- •Adequate iron status, serum ferritin >= 100 µg/L or transferrin saturation >= 20%
- •Ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration
- •Written informed consent of the patient.
排除标准
- •Anemia of non-renal causes
- •Therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis)
- •Patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis)
- •Patients with acute deterioration of renal function during the screening phase according to the investigator's judgment
- •Patients receiving any RBC/whole blood transfusion during the screening period
- •Primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
- •Evidence of uncontrolled diabetes mellitus (HbA1c > 10 % at visit -2)
- •Evidence of severe hepatic dysfunction (e.g. ALT and/or AST above 2x upper limit of normal range; or gamma-GT above 3x upper limit of normal range)
- •Clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone > 500 ng/L at visit -
- •Uncontrolled hypertension, defined as a systolic blood pressure of >= 160 mmHg and a diastolic blood pressure measurement >= 100 mmHg (average of two values with at least one day between measurements)
- •Congestive heart failure and/or angina pectoris [New York Heart Association (NYHA) class III and IV]
- •History of stroke or myocardial infarction during the last 6 months prior to visit -2
- •Ongoing treatment with phenprocoumon or other cumarin derivates
- •Thrombocytopenia (platelet count <100.000/µL) or leucopenia (white blood cell count < 2.000/µL)
- •Gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis
- •Evidence of acute or chronic infection by a C-reactive protein value of > 30 mg/L
- •Suspicion or known PRCA (pure red cell aplasia)
- •Previously diagnosed HIV or acute hepatitis infection
- •History of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening
- •Planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery)
- •Clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer)
- •Pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, IUD, sexual abstinence, vasectomised partner)
- •Known history of severe drug related allergies (e.g. anaphylactic shock)
- •Known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products
- •Known or suspicion of any non-compliance with respect to subcutaneous treatment
- •Simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study
- •Participation in another ESA study in the 3 months preceding visit -2
- •Any other condition which at the investigator's discretion may put the patient at risk or which may confound the study results.
研究组 & 干预措施
1
Experimental
HX575, EPO HEXAL
干预措施: HX575 recombinant human erythropoietin alfa (Drug)
2
Active Comparator
ERYPO
干预措施: ERYPO (Drug)
结局指标
主要结局
Change in Hemoglobin Level
时间窗: 13 weeks
Mean absolute change in hemoglobin (baseline to end of study week 13)
Weekly Epoetin Dose
时间窗: weeks 11-13
Mean weekly epoetin dose \[IU/kg\] in study weeks 11-13
次要结局
- Immunogenicity(13 weeks)
研究者
研究点 (116)
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