EUCTR2007-001394-29-IT进行中（未招募）不适用
Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of PPEN vs DDDD in Diabetic CAPD Patients - The IMPENDIA trial - IMPENDIA
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 236
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
- •Diabetic (Type 1 and 2) patients of either sex aged 18 years or older with a diagnosis of end-stage renal disease (ESRD) (GFR ≤ 15 mL/min) who have been performing CAPD for at least 30 days and using only Dianeal solutions will be enrolled in the study. Patients must be of stable clinical condition, have a daily CAPD prescription of Dianeal that includes at least one exchange of 2.5% or 4.25% dextrose (2.27% or 3.86% glucose) with no prescribed dry time, require glycemic-control with insulin and/or oral hypoglycemic agents, have HbA1c of > 6.0% but ≤ 10.0%, have a blood hemoglobin ≥ 9.0 but ≤ 13.0 g/dL, have a total Kt/V ≥ 1.7, and be expected to remain on CAPD for at least 6 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
- •Patients in Automated Peritoneal Dialysis; pregnant or lactating women; patients with cardiovascular disorders; patients whose abdominal wall is compromised for any disease or intervention; patients with active liver diseases or active infections or past severe infections; patients with allergies or intolerance to any component of the dialysis solutions; patients with malignancies; patients who received antibiotics in the last 30 days; patients with psichiatric disorders; HIV patients.
研究者
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Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of Physioneal, Extraneal, Nutrineal (P-E-N) vs Dianeal Only Treatment in Diabetic CAPD and APD Patients – The IMPENDIA Trial. (Revised per Amendment A.) - IMPENDIAEnd stage renal disease patients with Diabetes Type I and II on Continuous Ambulatory Peritoneal Dialysis and Automated Peritoneal DialysisMedDRA version: 9.1Level: LLTClassification code 10012660Term: Diabetic end stage renal diseaseEUCTR2007-001394-29-PTBAXTER HEALTHCARE CORPORATIO236
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