JPRN-jRCTs051180048已完成未知
Evaluation for new Phosphate Iron-based binder , Sucroferric Oxyhydroxide in Dialysis patient for E.B.M - EPISODE
Isaka Yoshitaka0 个研究点目标入组 203 人开始时间: 2019年2月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 203
研究概览
简要总结
We observed significant difference of percent change in CACS within Standard control and Strict control (p=0.006).Strict control may retard the progression of CACS among dialysis patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1.Patients with hyperphosphatemia in chronic maintenance dialysis.
- •2.Patients of the following serum P concentration before dialysis in observation period.
- •In the case of patients with medication, the phosphorus adsorbent in the observation period is serum P concentration of 5.0mg/dL or more.
- •In the case of patients with not medication, the phosphorus adsorbent in the observation period is serum P concentration of 6.1mg/dL or more.
- •3.Patients have elapsed dialysis after more than three months
- •4.Patients have received three times a week or more of stable hemodialysis (HD or HDF), and patients will continue to similar blood dialysis until the end of the treatment period start.
- •5.CACS of a patient is more than 30 that is measured during the observation period.
- •6.Patients are older 20-year-old or less than 80-year-old.
- •7.Outpatients
- •8.Gender does not matter.
- •9.Patients were obtained informed consent.
排除标准
- •1.Before dialysis, serum intact-PTH concentration of previously registered one month is exceeds 800 pg/mL or over 500pg/mL, it is determined that the uncontrolled.
- •2.Patients have hemochromatosis or patients have a history of other iron storage disorders, or serum ferritin concentration before dialysis of the observation period at the start is over 300ng/mL or TSAT is more than 50%.
- •3.Patients have severe liver dysfunction (C chronic hepatitis, etc.).
- •4.Patients have severe coronary artery disease
- •5.Patients are merged malignant tumor.
- •6.Patients are paroxysmal nocturnal hemoglobinuria.
- •7.Patients have hypersensitivity iron-containing formulations or lanthanum-containing formulations.
- •8.Patients received PTX.
- •9.Patients suspect of being pregnant or pregnant.
- •10.Research investigators or research sharing investigators have determined to the patient is inappropriate as a subject of the study.
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