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. - NI
Kyowa Hakko Kirin Co Ltd0 个研究点目标入组 126 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria for first registration:
- •Following patients will be included in the study at first registration:
- •1. Male or female patients diagnosed with CRF, aged 18 to 80 years, inclusive.
- •2. 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
- •2. 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.
- •3. 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
- •5. 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
研究者
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