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临床试验/JPRN-UMIN000008505
JPRN-UMIN000008505已完成4 期

A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD). - A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD).

Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine0 个研究点目标入组 36 人开始时间: 2012年7月23日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
36

研究概览

简要总结

Office/ambulatory BP, renal function, and other parameters were not significantly different between groups. Although office/ambulatory BP profiles had not worsened after 24 weeks of ESA treatment, more than half of the patients required an increase in the antihypertensive agent dose.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1.Severe hypertension(diastolic blood pressure is over 100 mmHg within 12 weeks) 2.Congestive heart failure(NYHA class3, 4) 3.Pregnant women and/or women who are suspect of pregnancy 4.History or complication of cardiac infarction, pulmonary embolism or symptomatic cerebral infarction 5.History of hypersensitivity to epoetin beta pegol and/or darbepoetin alpha 6.Patients with malignancy, severe infection, systemic blood disease(MDS, etc.), hemolytic anemia or hemorrhagic disease 7.Administration of anabolic steroids, testosterone enanthate or mepitiostane within 12 weeks 8.Erythrocyte transfusion within 16 weeks 9.Patients who will plan to undergo a severe bleeding surgery 10.Patients judged as inappropriate for the study

研究者

发起方
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine

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EUCTR2007-002562-35-FRCHU AMIENS