NCT01331317已完成4 期
The Effect of Paricalcitol Versus Placebo on Plasma N-Terminal-proBNP in Patients With Type 1 Diabetes Mellitus and Diabetic Nephropathy
Peter Rossing1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in plasma NT-proBNP
研究概览
简要总结
The primary objective is to assess the impact of three months of treatment with an active vitamin D analogue on a risk marker for excess overall mortality and cardiovascular morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. The hypothesis is that active vitamin D analogue treatment reduces the risk of cardiovascular morbidity and mortality in patients with type 1 diabetic kidney disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age
- •Type 1 diabetes mellitus
- •Diabetic nephropathy (defined by persistent albuminuria, > 300 mg/24 hr or 200µg/min in 2 of 3 consecutive samples, presence of diabetic retinopathy and absence of clinical or laboratory evidence of other kidney or renal tract disease
- •Chronic kidney disease stage 3 and 4
- •S-Parathyroid hormone (s-PTH)> 35pg/ml
- •Stabile RAAS-blocking and diuretic treatment
排除标准
- •Other kidney disease than diabetic nephropathy
- •Myocardial infarction within the last three months prior to visit 1
- •Coronary artery revascularization within the last three months prior to visit 1
- •Transitional cerebral ischemia (TCI) or apoplexia within the last three months prior to visit 1
- •Cardiac Failure (NYHA Class III or IV)
- •Kidney Failure (GFR <15ml/min), dialysis, kidney transplantation)
- •Liver disease with serum alanine aminotransferase (ALT>3 x the normal value
- •Alcohol/drug abuse
- •Hypercalcemia (serum ionized calcium >1.35 mmol /L)
- •Medication with phosphate and/or vitamin D-containing medications, which can not be paused during the study
- •Clinical signs of vitamin D toxicity
- •Pregnant or nursing women
- •Fertile women not using chemical or mechanical (IUD) contraceptive methods
- •Current disulfiram treatment
- •Allergy to the study drug
- •Patient unable to understand the informed consent
- •Any other condition or therapy which, in the opinion of the investigator, makes the patient not suited for participation.
研究组 & 干预措施
Paricalcitol
Other
Crossover study between paricalcitol and placebo
干预措施: Paricalcitol (Drug)
结局指标
主要结局
Change in plasma NT-proBNP
时间窗: 7 months
次要结局
- Change in Glomerular Filtration Rate (GFR)(7 months)
- Change in Urinary Albumin Excretion Rate(7 months)
研究者
Peter Rossing
Senior Physician, DMSc
Steno Diabetes Center Copenhagen
研究点 (1)
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