CTRI/2010/091/000580招募中4 期
A single arm open label Multicenter interventional study to assess the efficacy, safety, and tolerability of every 4 weeks administration of subcutaneous C.E.R.A. (Continuous erythropoietin receptor activator) for the treatment of chronic renal anaemia in Diabetic Nephropathy with chronic kidney disease stages III-IV not on dialysis, not currently treated with ESA. (Erythrocyte Stimulating Agents )
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
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
入选标准
- •Adult patients, greater than equal to 18 years of age
- •Diabetic nephropathy
- •Chronic renal anaemia with stage III-IV chronic kidney disease
- •Not on dialysis and not expected to require dialysis within the next 6 months
- •Not receiving any erythropoiesis stimulating agent (ESA) in the 2 months prior to study
- •Adequate iron status
排除标准
- •? Transfusion of red blood cells during the previous 2 months
- •? Known Folic acid deficiency or MCV > 105 fL
- •? Known Vitamin B12 deficiency or MCV > 105 fL
- •? Platelet count >500 x 109/L or <100 x 109/L
- •? Known or clinical suspicion of pure red call aplasia (PRCA)
- •? Pregnancy or lactation period and 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
- •? Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •? Disease states like: Significant acute or chronic bleeding, Hemoglobinopathies (e.g homozygous sickle-cell disease, thalassemia of all types), Uncontrolled or symptomatic secondary hyperparathyroidism, Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100mm Hg, poorly controlled diabetes (HbA1C > 9 % ) Epileptic seizure during previous 6 months, Myocardial infarction or stroke, severe or unstable CAD, Severe liver disease, Congestive heart failure (NYHA Class III-IV) during the previous 3 months.
- •? Patient with significant change (> or = 50%) in the dose of Thiazolidinediones (TZD) in previous 2 months.
- •? Planned (date) elective surgery during the study period except for cataract surgery and vascular access surgery
- •? Any other concomitant conditions which as per investigators opinion may affect patient?s interest and compliance to this protocol.
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