Evaluation for new Phosphate Iron-based binder , Sucroferric Oxyhydroxide in Dialysis patient for E.B.M - EPISODE

Osaka University Graduate School of Medicine Department of Nephrology0 个研究点目标入组 200 人开始时间: 2016年8月17日最近更新: 2023年10月17日

适应症

试验速览

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•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.

发起方

Osaka University Graduate School of Medicine Department of Nephrology