Influence of Pioglitazone for Renal Transplant Function in Diabetics - a Double Blind Randomised Placebo Controlled Cross Over Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- proteinuria
研究概览
简要总结
The purpose of this study is to test whether pioglitazone is able to prevent the progression of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.
详细描述
About 30 % of kidney transplant recipients will develop diabetes mellitus. This condition is a risk factor for graft dysfunction, graft loss and increased mortality of patients. Inflammatory reactions within the graft and proteinuria are considered as pathogenetic mechanisms.
Recent studies indicated that pioglitazone might have beneficial effects on the urinary protein excretion of type 2 diabetic patients with diabetic nephropathy and was able to reduce systemic inflammation.
This lead to the hypothesis that pioglitazone could improve proteinuria of kidney transplant patients with diabetes.
Comparison: Effects of pioglitazone vs. placebo on proteinuria and renal function of kidney transplant recipients in a cross over study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •kidney transplantation(> 6 months ago) ; stable graft function
- •diabetes mellitus type 2
- •acceptable glycemia (HbA1c < 8%)
- •creatinin clearance (MDRD)>30 ml/min 1,73m²)
- •proteinuria > 30 mg/24 hr
排除标准
- •type 1 diabetes
- •pregnant or breast feeding women
- •congestive heart failure (>stage 1 NYHA)
- •creeping creatinin
- •treatment for rejection within 3 months prior to inclusion
- •ALT, AST > 2.5 fold the upper limit of normal
- •uncontrolled hypertension
- •hypo- or hyperthyroidism
结局指标
主要结局
proteinuria
时间窗: 12 weeks
次要结局
- efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema(12 weeks)