NCT00368901已完成4 期
A Multicenter Study Using Once Every Other Week Subcutaneous Administration of Aranesp™ (Darbepoetin Alfa) and Iron Guided Algorithms to Treat Subjects With Anemia of Chronic Renal Insufficiency (CRI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 618
- 主要终点
- Mean hemoglobin during the evaluation period
研究概览
简要总结
To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.
详细描述
To assess the effect of Aranesp_ on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy. To assess the association between subject self-reported health-related quality of life (HRQoL) as it relates to Hgb concentration and glomerular filtration rate (GFR) in subjects who were rHuEPO-naïve prior to study enrollment. To characterize the health-related resource utilization of subjects with CRI. To characterize the subject satisfaction with Aranesp_ compared to previous rHuEPO therapy. To characterize iron treatment in subjects with CRI. To assess the safety profile of Aranesp_ therapy in subjects with CRI
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥ 18 years old
- •diagnosis of CRI and not receiving dialysis therapy (must be predialysis)
- •measured or estimated (using the Cockcroft-Gault formula) creatinine clearance (CrCl) of ≤ 70 mL/min, or GFR ≤ 60 mL/min (using the MDRD formula):
- •Cockcroft-Gault formula: CrCl = (140 minus age in years) x (body weight in kg) serum creatinine (mg/dL) x 72.0 For women, the value will be multiplied by 0.85
- •MDRD formula: GFR = 170 x [SCr]-0.999 x [Age]-0.167 x [0.762 if subject is female] x [1.180 if subject is black] x [sun] -0.170SAlb]-0.318
- •mean Hgb < 11 g/dL during the screening/baseline period (if subject is not already receiving rHuEPO therapy)
- •for subjects currently receiving rHuEPO therapy, the subject must have: a stable rHuEPO dose for the past month; and a rHuEPO frequency of once weekly.
- •white blood cell and platelet counts within normal limits
- •serum vitamin B12 and folate levels above the lower limit of normal range
- •transferrin saturation (TSAT) ≥ 20% during the screening period
- •availability for follow-up assessments
- •subject must be able to comprehend and be willing to, or have legally accepted representative, give written informed consent for participation in the study
排除标准
- •scheduled to initiate dialysis
- •uncontrolled hypertension (diastolic blood pressure > 105 mm Hg or systolic blood pressure of > 180 mm Hg during the screening/baseline period on two separate measurements)
- •clinically unstable in the judgment of the investigator (eg, subject is in the intensive care unit, immediately post-myocardial infarction, etc)
- •scheduled to receive a living donor kidney transplant
- •treatment of grand mal epilepsy within the past 6 months
- •moderate to severe congestive heart failure (NYHA class III or IV)
- •clinical evidence of severe secondary hyperparathyroidism (parathyroid hormone level > 1500 pg/mL)
- •severe active chronic inflammatory process (eg, ulcerative colitis, peptic ulcer disease, rheumatoid arthritis, etc)
- •currently receiving antibiotic therapy for systemic infection (enrollment may be postponed until the course of antibiotics has ended)
- •known aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of the normal range on more than one occasion within three months prior to screening
- •known positive HIV antibody or hepatitis B surface antigen
- •clinical evidence of current malignancy and/or receiving chemotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
- •active bleeding or RBC transfusion within eight weeks of enrollment
- •androgen therapy within four weeks before enrollment
- •known hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma; hemolytic anemia, etc)
- •any condition that is likely to affect subject compliance
- •currently or previously (within 30 days) enrolled in investigational device or drug trial(s) or receiving investigational agent(s)
- •the exception to this is if the subject was enrolled in another Aranesp™ or rHuEPO protocol
- •pregnant or breast feeding women (women of child-bearing potential must be using contraceptive precautions)
- •women planning to have a child during the study period
- •known hypersensitivity to the active substance or any of the excipients
研究组 & 干预措施
Single arm
Experimental
Every other week dosing of Aranesp SC
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Mean hemoglobin during the evaluation period
时间窗: 52 weeks
次要结局
- Change in hemoglobin throughout the study(52 weeks)
- HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study(52 weeks)
- Health-related resource utilization, measured every 4 weeks, throughout the study(52 weeks)
- Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12(12 weeks)
- Iron requirement (dose, frequency, and route) of subjects during the study(52 weeks)
研究者
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