EUCTR2009-011255-44-DK进行中（未招募）1 期
The effect of paricalcitol versus placebo on plasma NT-proBNP in patients with type 1 diabetes mellitus and diabetic nephropathy - DiaZemp
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •1. 18-75 years of age
- •2. Type 1 diabetes mellitus (WHO criteria)
- •3. Diabetic nephropathy
- •4. Chronic kidney disease (eGFR/GFR 15-70ml/min/1.73m2)
- •5. Parathyroid hormone analysis, s-iPTH> 35pg/ml (analysed at visit 0 and with possibility of re-analysis within a week, the last analysed value being conclusive)
- •6. Stabile RAAS-blocking and diuretic treatment
- •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
- •1.Diagnosed with other kidney disease than diabetic nephropathy
- •2. Myocardial infarction within the last three months prior to visit 1
- •3. Coronary artery revascularization within the last three months prior to visit 1
- •4. Transitional cerebral ischemia (TCI) or apoplexia within the last three months prior to visit 1
- •5. Cardiac Failure (NYHA Class III or IV)
- •6. Kidney Failure (GFR <15ml/min), dialysis, kidney transplantation
- •7. Liver disease with serum alanine aminotransferase (ALT) increased to more than three times the normal value (analysed at visit 0 and with possibility of re-analysis within a week, the last analysed value being conclusive)
- •8. Alcohol/drug abuse
- •9. Hypercalcemia defined as serum ionized calcium >1.35 mmol /L (analysed at visit 0 and with possibility of re-analysis within a week, the last analysed value being conclusive)
- •10 Medication with phosphate and/or vitamin D-containing medications, which can not be paused during the study
- •11. Clinical signs of vitamin D toxicity
- •12 Pregnant or nursing women
- •13 Fertile women not using chemical (contraceptive pills, depot injection of depot gestagen, contraceptive implant, vaginal hormonal ring, birth control patch) or mechanical (IUD) contraceptive methods
- •14 Current disulfiram treatment
- •15 Allergy to the study drug
- •16 Patient unable to understand the informed consent
研究者
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