EUCTR2005-003302-28-LT进行中（未招募）不适用
MAINTENANCE PHASE STUDY” A THERAPEUTIC EQUIVALENCE STUDY COMPARING THE EFFICACY AND SAFETY OF INTRAVENOUS EPOETIN (PLIVA) AND EPOETIN ALFA (JANSSEN CILAG) IN PATIENTS WITH CHRONIC RENAL FAILURE REQUIRING HEMODIALYSIS AND RECEIVING EPOETIN MAINTENANCE TREATMENT A multinational, multicenter, randomized, comparator controlled, parallel-group, double blind phase III study
PLIVA Research and Development Ltd.0 个研究点目标入组 256 人开始时间: 2005年8月30日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 256
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Have chronic renal failure requiring regular hemodialysis, and receiving at least 6 months r HuEPO treatment (75 300 international units [IU]/kg per week either iv or subcutaneous) of which at least 3 months should be r-HUEPO maintenance therapy, prior to the Screening Visit.
- •2.The hemodialysis is of adequate quality, defined as fractional urea clearance (Kt/Vurea) ³ 1.2 (within the 4 weeks prior to the Screening Visit).
- •3.Have controlled Hb level of 10 to 13 g/dL during the last 8 weeks prior to the Screening Visit (mean value of 3 measurements 10-13 g/dL, difference between highest and lowest value no more than 2 g/dL, measurements at least 1 week apart). Be on stable dose of epoetin, i.e., no dose change during the last 8 weeks of r-HUEPO treatment.
- •4.Are clinically stable (based on the investigator’s judgment) within the 3 months prior to the Screening Visit.
- •5.Have adequate iron stores (serum ferritin > 100 mg/L and TfS > 20%) at the Screening Visit. Patients who meet all other criteria will be given iron therapy and be re-screened after 2 weeks. All study assements of the screening visit (exept for written informed consent; demographics/medical history, serology; vitamin B12 and folic acid) must be repeated as soon as the time between the screening and first dosing exeeds 2 weeks (+ 3 day window). The type of iron therapy chosen will be at the discretion of the investigator, and according to local requirements.
- •6.Are aged 18 to 75 years.
- •7.Females of childbearing potential must have a negative serum pregnancy test at screening and be practicing an acceptable method of birth control during the study and for up to 1 month after the last dose of the study drug.
- •Acceptable methods (which have a failure rate of < 1% a year) include: hormonal implants and injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomized partners. Female patients must not be nursing an infant during the study. Sexually active male patients must take appropriate actions to avoid pregnancy with any partner.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Have had treatment with long-acting epoetin analogues, such as Aranesp, or are receiving maintenance does of r-HuEPO >300 IU/kg per week.
- •2.Have had treatment for epilepsy with tonic clonic seizures within 6 months prior to the Screening Visit.
- •3.Have congestive heart failure (New York Heart Association [NYHA] class III or IV).
- •4.Have had a cerebrovascular accident, myocardial infarction, coronary angioplasty or bypass surgery within 6 months prior to the Screening Visit.
- •5. Have uncontrolled hypertension, defined as 2 diastolic blood pressure measurements > 110 mmHg, and/or 2 systolic measurements > 180 mmHg, taken after dialysis within the 4 weeks prior to the Screening Visit. If one blood pressure measurement is increased above limits, another measurement will be taken after a 30 minute interval for confirmation.
- •6.Have had major surgery within 3 months prior to the Screening Visit (excluding vascular access surgery).
- •7.Have active inflammatory or malignant disease.
- •8.Have been previously diagnosed with human immunodeficiency virus (HIV) or chronic hepatitis B or C virus infection. Patients who are hepatitis B surface antigen (HbsAg) or hepatitis C virus antibody (anti HCV) positive can be included if they have normal transaminases and are not on anti viral treatment.
- •9.Have had a RBC transfusion(s) within 3 months prior to the Screening Visit or during the screening Period, or have chronic bleeding or clinically significant blood loss.
- •10.Have any anemia with a cause other then chronic renal failure (e.g., hemolytic anemia including sickle cell disease, megaloblastic anemia, aplastic anemia, myelodysplasia, pure red cell aplasia).
- •11.Are currently enrolled in any other investigational device or drug study, or have participated in another clinical study within 30 days prior to the Screening Visit.
- •12.Are pregnant women or mothers who are breast feeding.
- •13.Have a known hypersensitivity (drug intolerance or allergy) to r HuEPO, epoetin alfa (Janssen Cilag), or excipients of epoetin (PLIVA).
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