CTRI/2011/03/001655Other3 期
A Randomized, Open-Label, Two-Arm, multicentric, Phase III Comparative Study between Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Eythropoietin (r-HuEPO) for Treatment of Renal Anaemia in Patients with Chronic Renal Failure (CRF) Receiving HemoDialysis.
Kyowa Hakko Kirin Co Ltd15 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2011年12月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 126
- 试验地点
- 15
- 主要终点
- Changes in Hemoglobin (Hb) level in between the baseline period and the evaluation period
研究概览
简要总结
Study Design: This study is a randomized, open-label, two-arm, multicentric, phase-III trial comparing two drugs; novel erytropoiesis stimulating protein (NESP) and Recombinant Human Erythropoietin (r-HuEPO).
Study Duration: The study duration is 32 weeks for each patient and includes 126 patients with anaemia in chronic renal failure; the study will be conducted at five centers in India.
Primary Outcome: The primary outcome will be changes in Hemoglobin (Hb) level between the baseline period and the evaluation period.
Secondary Outcome: The secondary outcome will be evaluation unstable Hb levels during the evaluation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria for first registration: Following patients will be included in the study at first registration:
- •Male or female patients diagnosed with CRF, aged 18 to 80 years, inclusive.
- •Patient/LAR (legally acceptable representative)of patient willing to sign and date written informed consent to participate in the study.
- •However, if the patient/LAR of patient is illiterate, the impartial witness would sign the ICF.
- •3.Patients receiving HD two to three times per week for at least 12 weeks before first registration 4.Patients with no planned change in dialysis modality and with no planned renal transplant.
- •5.Patients managing renal anaemia by receiving an administration of r-HuEPO intravenous or sub-cutaneous (at least once per week) for at least 8 weeks before the first registration Inclusion criteria for second registration: 1.Patients receiving HD (includes hemodialysis filtration) two to three times per week for 8 weeks after the first registration
- •Patients who received sub cutaneous r HuEPO before first registration and then are continued and stabilized on IV administration of r HuEPO during the 8 weeks of Screening and Baseline period before second registration.
- •Patients receiving an administration of IV r-HuEPO product twice or three times weekly (dose levels 2, 3 and 4) for 8 weeks after the first registration.
- •4.Patients with at least 9.0 g/dL and less than or equal to 12.0 g/dL of the average Hb concentration during the baseline period (Week -4, Week -3, Week -2 and Week 1) 5.Patients with at least 9.0 g/dL and less than or equal to 12.0 g/dL of the average Hb concentration during the screening period (Week -7, -6 and -5) 6.Patients with at least 20% of TSAT and more than or equal to 100 ng/mL of ferritin at the test during the baseline period (Week -4 or -2).
排除标准
- •Exclusion criteria for second registration: 1.Patients with uncontrolled hypertension (patients with over 100 mm Hg of diastolic blood pressure before HD at over 1/3rd of the BP measurements for 12 weeks before the second registration 2.Patients with congestive heart failure (CHF) of grade III or higher (as per New York Heart Association Class III) 3.Patients with malignancy (including hematologic malignancy), systemic blood disorder (myelodysplastic syndrome, pure red cell aplasia, hemolytic anaemia, or the like) 4.Patients who have known human immunodeficiency virus (HIV) infection
- •Patients who have received an administration of anabolic hormone or testosterone enanthate within 12 weeks before the second registration.
- •6.Patients who had received administration of another study drug within 12 weeks before the second registration 7.Patients who have previously received an administration of darbepoetin 8.Patients who are confirmed to have a serious allergy or serious drug allergy 9.Patients who are hypersensitive to r-HuEPO 10.Female patients who are pregnant, breast feeding, or suspected to be pregnant 11.Patients whose aspartate transaminase (AST)/ serum glutamate oxaloacetate transaminase (SGOT) or alanine transaminase (ALT)/ serum glutamate pyruvate transaminase (SGPT) is 2 times the institutional upper normal limit at the test during the baseline period (Week 4) 12.Patients who have undergone major surgery associated with major bleeding within 16 weeks before the second registration (excluding vascular access surgery) 13.Patients who have received a blood transfusion within 16 weeks before the second registration 14.Patients with immunosuppressive therapy 15.Patients who are judged by the investigators to be ineligible for participation in this study.
结局指标
主要结局
Changes in Hemoglobin (Hb) level in between the baseline period and the evaluation period
时间窗: Day -49 to Day 168
次要结局
- Unstable Hemoglobin (Hb) level during the evaluation period(Day 0 to Day 168)
研究者
研究点 (15)
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