PER-041-08已完成未知
An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.
PRODUCTOS ROCHE Q.F.S.A.,0 个研究点目标入组 0 人开始时间: 2008年8月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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 至 95（—）
入选标准
- •Written informed consent
- •18 years of age or older
- •Chronic renal anemia
- •Hemoglobin concentration> 8.5 g / dL and <10.0 g / dL
- •Adequate iron status (serum ferritin> 100 ng / mL OR TSAT> 20% OR hypochromic red blood cells <10%)
- •No previous therapy with ESA 3 months before enrollment
- •Estimated GFR (eGFR) <60 ml / min and> 20 ml / min
排除标准
- •Transfusion of red blood cells during the two months before enrollment
- •Rapid progression of CKD, that is, a reduction in eGFR of more than 10 mL within the last 3 months
- •Poorly controlled hypertension, that is, seated blood pressure exceeding 170/100, despite medication
- •Significant chronic or acute bleeding such as obvious gastrointestinal bleeding
- •Active malignant disease (except non-melanoma skin cancer)
- •Hemolysis: haptoglobin <30 mg / dl (3.54) umol / L) or other reliable positive hemolysis test.
- •Hemoglobinopathies (eg, homozygous sickle cell disease, thalassemia of all types).
- •Folic acid deficiency, not corrected in the past 2 months judged by local laboratory values, for example, erythrocyte MCV> 105 fL.
- •Vitamin B12 deficiency, not corrected in the past 2 months judged by local laboratory values, for example, erythrocyte MOV> 105 fL.
- •Platelet count> 500 x 10 9 / L or <100 x 10 9 / L
- •Simple (pure) aplasia of red blood cells
- •Epilepsy attack during the previous 6 months
- •Congestive heart failure (NYHA Class IV)
- •Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease at the discretion of the investigator, during the previous 3 months
- •Hyperparathyroidism not controlled or secondary by symptoms, PTH> 600
- •Pregnancy or lactation period
- •Women with pregnancy potential without effective contraception
- •Participation in a clinical trial or receipt of a research or treatment compound during the previous 3 months
- •Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol, or any other constituent of the study medication.
- •Planned elective surgery (date) during the study period, except for: a Cataract surgery b Vascular access surgery
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