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临床试验/TCTR20190718006
TCTR20190718006招募中4 期

A RANDOMIZED, CONTROLLED, OPEN-LABEL, SINGLE-CENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFECT OF MIRCERA ON DELAYING DIALYSIS IN ANEMIC PATIENTS WITH STAGE 5 CHRONIC KIDNEY DISEASE NOT ON DIALYSIS

Department of Nephrology Unit Faculty of Medicine Chulalongkorn University0 个研究点目标入组 200 人开始时间: 2019年7月18日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 80 Years(—)
性别
All

入选标准

  • 1. CKD patients who are not on dialysis
  • 2. eGFR 8 and more and less than 15 mL/min/1.73m2 determined twice in last 12 weeks.
  • 3. CKD patients with renal anemia at Hb less than 10 g/dL in screening
  • 4. CKD patients with TSAT 20% and higher or serum ferritin 100ng/mL and higher.
  • 5. CKD patients treated with standard care
  • 6. CKD patients provided written informed consent.

排除标准

  • . Uncontrolled hypertension (180/100 mmHg and higher)
  • 2. Heart failure (NYHA III and IV)
  • 3. Malignancy, hematological disorder
  • 4. Malnutrition
  • 5. Active and continuous gastrointestinal tract bleeding
  • 6. Planned kidney transplant within 6 months
  • 7. Myocardial infarction within last 6 months
  • 8. Stroke or pulmonary embolism within last 12 months
  • 9. Pregnant women, women on lactation, or CKD patients who plan to get pregnant
  • 10. Allergy against erythropoietin

研究者

发起方
Department of Nephrology Unit Faculty of Medicine Chulalongkorn University

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