NCT02136563已完成不适用
oBservational Clinical Research In Chronic Kidney Disease Patients With Renal Anemia : Renal proGnosis in Patients With Hyporesponsive Anemia To Erythropoiesis Stimulating Agents, darbepoetiN Alfa
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2014年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Cardiovascular disease events
研究概览
简要总结
This is an observational clinical research on patients with chronic kidney disease who are not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major objective is to explore novel erythropoiesis stimulating agent (ESA) response index in association with deterioration of renal function as well as occurrence of cardiovascular disease events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are planning to start treatment with darbepoetin alfa within 8 weeks after enrollment,
- •Patients with eGFR <60 mL/min/1.73m2 at the latest examination performed within 8 weeks before enrollment,
- •Patients with a hemoglobin level <11.0 g/dL at the latest examination performed within 8 weeks before enrollment,
- •Patients aged at least 20 years or older at the time of providing informed consent,
- •Patients who voluntarily provided written informed consent to participate in the study.
排除标准
- •Patients who are planning to start hemodialysis or to have a renal transplant within 24 weeks after enrollment,
- •Patients with a history of treatment with ESA except the ones who were treated temporarily more than 12 weeks before the enrollment,
- •Patients with malignant tumor, hematological disease, or hemorrhagic lesions,
- •Patients with hypersensitivity to ESA or any ingredient thereof,
- •Pregnant, lactating or possibly pregnant women or those who wish to become pregnant during the study period,
- •Patients who are participating in other clinical study,
- •Patients who are assessed as not eligible for the study by the investigator.
结局指标
主要结局
Cardiovascular disease events
时间窗: For ninety six weeks after starting to administer darbepoetin alfa
Deterioration of renal function
时间窗: For ninety six weeks after starting to administer darbepoetin alfa
次要结局
- Declination rate of estimated glomerular filtration rate(eGFR)(For ninety six weeks after starting to administer darbepoetin alfa)
- Safety assessment for every adverse event resulting from darbepoetin alfa administration(For ninety six weeks after starting to administer darbepoetin alfa)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
oBservational clinical Research In chronic kidney disease patients with renal anemia :renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis stimulating agents,darbepoetiN alfaRenal anemia in chronic kidney diseaseJPRN-UMIN000013464iigata University Graduate School of Medical & Dental Sciences2,000
已完成
不适用
An Observational Study to Learn More How Chronic Kidney Disease Gradually Changes Over Time in Adults Using Electronic Healthcare Records (CKD Natural History Study)Chronic Kidney DiseaseNCT05914259Bayer969,394
已完成
3 期
FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney DiseaseChronic Renal FailureNCT01220843Centre Hospitalier Universitaire, Amiens98
Unknown
不适用
Prevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart DiseaseChronic Kidney DiseaseCoronary Heart DiseaseNCT02509013Peking University First Hospital10,000
招募中
不适用
Randomized trial for the chronic kidney disease patients by phosphate binder for prevention of vascular calcification in Juntendo University Hospitalchronic kidney disease patientsJPRN-UMIN000019385Department of internal Medicine, Juntendo University Faculty of Medicine200