NCT01136564已完成2 期
Reno- and Vascular Protective Effect of a Low-calcemic Vitamin-D-analogue (Paricalcitol) in Stage III-IV Chronic Kidney Disease
Erling Bjerregaard Pedersen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- plasma renin concentration
研究概览
简要总结
Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. In clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney disease corresponding to eGFR: 15-59 ml/min
- •Albuminuria > 30 mg/l
排除标准
- •Total parathyroidectomy
- •Diabetes Mellitus
- •Illicit drug or alcohol abuse
- •Pregnancy og nursing
- •Ongoing NSAID or corticosteroid treatment
- •b-hemoglobin < 6 mmol/l
- •p-albumin < 25 mmol/l
- •Clinically significant hypercalcemia
- •Office blood pressure > 170/105 mmHg that despite antihypertensive treatment still is > 170/105 mmHg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement.
研究组 & 干预措施
Paricalcitol
Active Comparator
干预措施: Zemplar (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
plasma renin concentration
时间窗: 6 weeks
次要结局
- Urinary excretion of NCC(6 weeks)
- Urinary excretion of aquaporin-2(6 weeks)
- Urinary excretion of ENaC-beta(6 weeks)
- Urinary albumin excretion(6 weeks)
- GFR(6 weeks)
- Fractional excretion of sodium(6 weeks)
- Plasma concentration of aldosterone(6 weeks)
- Plasma concentration of angiotensin-II(6 weeks)
- Plasma concentration of ADH(6 weeks)
- Plasma concentration of atrial natriuretic peptide(6 weeks)
- Plasma concentration of brain natriuretic peptide(6 weeks)
- Plasma concentration of endothelin(6 weeks)
- 24-hr ambulatory blood pressure(6 weeks)
- Central blood pressure(6 weeks)
- Pulse wave velocity(6 weeks)
- augmentation index(6 weeks)
- Plasma concentration of ionized calcium(6 weeks)
- Plasma concentration of phosphate(6 weeks)
- Plasma concentration of alkaline phosphatase(6 weeks)
- Plasma concentration of Parathyroid hormon(6 weeks)
- Plasma concentration of 25-hydroxy-vitamin D(6 weeks)
- Plasma concentration of ultrasensitive CRP(6 weeks)
- Plasma concentration of TNF-alpha(6 weeks)
- Plasma concentration of TGF-beta(6 weeks)
- Urinary excretion of calcium(6 weeks)
- Plasma concentration of ADMA(6 weeks)
研究者
Erling Bjerregaard Pedersen
Professor, MD, MSci
Regional Hospital Holstebro
研究点 (1)
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