EUCTR2007-005528-34-BE进行中（未招募）不适用
Subcutaneous Treatment of Anemia in patients with a GFR Below 45 ml/min/1.73m2 through Injections with Mircera as low frequent as Once monthly - STABILO
.V. Roche S.A.0 个研究点开始时间: 2008年1月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent
- •Age 18 years or older
- •Chronic renal anaemia defined as a GFR < 45 ml/min/1.73m2 (MDRD)
- •Haemoglobin concentration = 9 and <11.0 g/dl
- •Adequate iron status serum ferritin >100 ng/mL AND TSAT>20% (OR hypochromic red cells <10%)
- •No ESA therapy during the previous 3 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Transfusion of red blood cells during the previous 2 months
- •Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization in the previous
- •Significant acute or chronic bleeding such as overt gastrointestinal bleeding
- •Active malignant disease (except non-melanoma skin cancer)
- •History of primary bone marrow diseases
- •Haemolysis
- •Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- •Folic acid deficiency
- •Vitamin B12 deficiency
- •Platelet count >500 x 109/L or <100 x 109/L
- •Pure red cell aplasia
- •Epileptic seizure during the previous 6 months
- •Congestive heart failure (NYHA Class IV)
- •Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the previous 3 months
- •Pregnancy or lactation period
- •Women of childbearing potential without effective contraception
- •Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous 3 months
- •Planned (date) elective surgery during the study period except for
- •cataract surgery
- •vascular access surgery
- •Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •History of organ transplantation
- •Life expectancy < 8 months
研究者
相似试验
进行中（未招募）
1 期
A Placebo Study Comparing Intravenous Iron with Saline in Treatment of Low Blood Count before Surgery in Patients with Cancer of the Kidney, Bladder or Lower Abdominal CavityEUCTR2013-004979-13-DKRigshospitalet, 2032
进行中（未招募）
1 期
Treatment of anemia (low red blood cells) with iron infusions in patients listed for a liver transplantatioiron deficiency anemiaEUCTR2017-000703-24-ATMedical University of Vienna; Department of Surgery; Division of Transplantation60
招募中
1 期
Phase 2 Study of Luspatercept in Adults and Adolescents with Alpha (a)-thalassemiaAlpha (a)-thalassemiaMedDRA version: 20.1Level: LLTClassification code: 10054659Term: Thalassemia alpha Class: 10010331CTIS2022-502328-35-00Celgene Corp.177
进行中（未招募）
1 期
The Effect of Treating Patients with Anaemia in Diabetic Nephropathy to different target haemoglobin levels with Epoetin Beta - Epoetin Beta in ADAnaemia in Diabetic NephropathyMedDRA version: 8.1Level: LLTClassification code 10002071Term: Anaemia NOSEUCTR2006-004775-35-GBBarts and the London NHS Trust
已完成
不适用
The effect of treating patients with anaemia in diabetic nephropathy to different target haemoglobin levels with epoetin betaAnaemia in diabetic nephropathyHaematological DisordersAnaemiaISRCTN66395033Barts and the London NHS Trust (UK)160