Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels (110- 129 g/L and 130 - 149 g/L) on Progression of Chronic Kidney Disease in Patients With Type 2 Diabetes and With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Decrease in Cockcroft's creatinine clearance between inclusion and end of two years follow-up period.
研究概览
简要总结
In type 2 diabetics, progression from chronic kidney disease to end stage renal disease may be slowed down by therapeutic interventions as angiotensin converting enzyme inhibitors use, control of high blood pressure and proteinuria, control of hyperglycaemia, protein intake restriction, smoking cessation.
Correcting anaemia in these patients may prevent impairment of renal function. International guidelines indicate that haemoglobin level has to be of 110 g/L in these patients. We conduct an interventional randomized trial to evaluate the potential benefit of an haemoglobin level of 130 g/L in patients with type 2 diabetes and with a chronic kidney disease defined by a Cockcroft's creatinine clearance of 25 - 60 ml/min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes. Age between 18 and 80 years, male or female. Cockcroft's clearance between 25 and 60 ml / min. Haemoglobin level superior to 100 g/L and strictly inferior to 130 g/L
排除标准
- •Malignancy Solid organ transplant Acute pathology in the two months before inclusion date Myocardial infarction, stroke, pulmonary embolism in the six months before inclusion date Contra-indication to martial treatment or EPO treatment Present inclusion in another clinical study Patient who cannot answer questions of SF36 questionnaire
结局指标
主要结局
Decrease in Cockcroft's creatinine clearance between inclusion and end of two years follow-up period.
次要结局
- Death
- Angina
- Stroke
- Peripheral acute ischemia, vascular angioplasty, surgical vascular bypass, amputation
- Heart failure
- Pulmonary embolism
- Deep venous thrombosis and haemodialysis fistula thrombosis
- Bacterial infectious disease
- Renal replacement therapy (dialysis or pre-emptive renal transplantation)
- Quality of life: SF 36 auto-questionnaire