A Prospective, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Oral Paricalcitol in Retarding Cardiac Hypertrophy, Reducing Inflammation and Atherosclerosis in Stage 3 - 5 Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in left ventricular mass index determined by MRI
研究概览
简要总结
The purpose of this study is to test the hypothesis that selective vitamin D receptor activation reduces left ventricular hypertrophy and ameliorates inflammation and atherosclerosis in stage 3 -5 chronic kidney disease.
详细描述
Cardiovascular disease is the leading cause of mortality and morbidity in patients with chronic kidney disease. According to a previous study, only 15.6% of the patients beginning dialysis therapy had a normal echocardiogram, with left ventricular hypertrophy, left ventricular dilatation and systolic dysfunction occurring in 40.7%, 28% and 15.6% of patients, respectively. In addition, these patients are at an accelerated risk of developing atherosclerosis. The Kidney Disease Outcome Quality Initiative guideline recently raised concerns of a high prevalence of vitamin D deficiency in chronic kidney disease patients not yet requiring dialysis treatment. In addition, very recent data suggested that vitamin D deficiency is an important predictor of mortality in end-stage renal disease patients. Furthermore, hemodialysis patients treated with paricalcitol, a selective vitamin D receptor activator, showed a significantly lower risk of cardiovascular death than those not receiving vitamin D therapy. A number of studies also showed positive benefit of vitamin D receptor activator treatment on regression of left ventricular hypertrophy in dialysis patients. However, there is so far no data in patients with stage 3 and 4 chronic kidney disease where a high prevalence of vitamin D deficiency and cardiac hypertrophy has been reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient with stage 3 -5 chronic kidney disease (that is, eGFR < 60 ml/min per 1.73m2) diagnosed for more than 2 months and not expected to start dialysis within the next 12 months, and
- •Patient with screening echocardiography showing evidence of left ventricular hypertrophy
- •Patient has not received vitamin D therapy in the previous 4 weeks
- •For entry into the Treatment Phase, the subject must have:
- •screening iPTH >= 55 pg/ml or 5.8pmol/L (determined by the Nichols second-generation assay or similar assay)
- •serum calcium < 10.2 mg/dL (2.55 mmol/L)
- •serum phosphorus =< 5.2mg/dL (1.68mmol/L)
- •Ca*P product < 54 mg2/dL2 (4.36mmol2/L2)
- •If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or is of childbearing potential and practicing birth control measures.
- •Patients who provide informed consent for the study
排除标准
- •Patient with a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
- •Patient with history of renal stones
- •Patient with current malignancy
- •Patients with clinically significant gastrointestinal disease or liver disease
- •Patient with acute renal failure in the recent three months
- •Patient with a history of drug or alcohol abuse within six months prior to the screening phase
- •Patient is known to be human immunodeficiency virus (HIV) positive.
- •Patient with evidence of poor compliance with diet and medication.
- •Patient currently receiving medications that may affect calcium, phosphorus metabolism such as calcitonin, cinacalcet, bisphophonates or vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
- •Patients with active granulomatous disease
- •Patient with pregnancy
- •Patients currently receiving glucocorticoid steroid or other immunosuppressive treatment or had been administered glucocorticoid or other immunosuppressive treatment for more than 14 days within recent 6 months.
- •Patients with contraindication for MRI examination
研究组 & 干预措施
1
paricalcitol
干预措施: paricalcitol (Drug)
2
placebo
干预措施: paricalcitol (Drug)
结局指标
主要结局
Change in left ventricular mass index determined by MRI
时间窗: 1 year
次要结局
- Change in left atrial and ventricular volumes, systolic and diastolic function, carotid intima-media thickness, flow mediated dilation, pulse wave velocity, serum inflammatory and cardiac biomarkers, intact PTH, 24-hour urine protein and renal function(1 year)
研究者
Dr. Angela Yee-Moon Wang
Dr.
The University of Hong Kong