Effect of Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study): a Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 127
- 试验地点
- 25
- 主要终点
- Albuminuria in proteinuric Chronical Kidney Disease patients
研究概览
简要总结
The purpose of this study is to estimate the differences between albuminuria values determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last observation caused by paricalcitol between the group of control and group of treatment.
详细描述
Clinical Trial to estimate UACR determined albuminuria differences between treatment and non-treatment groups from basal intake to last study-related observation. Patients should suffer proteinuric Chronical Kidney Disease and recovered levels of seric 25(OH)D. Also, this clinical trial tries to determinate the effect of paricalcitol over several metabolic and inflammatory parameters on patients.
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
- None
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
- •Informed consent signed
- •Patients will be men or women, between 18 and 75 years old.
- •Patients must have been taken an stable dosis of Angiotensine Converter Enzyme Inhibitor, Angiotensine Receptor Antagonism or antialdosterone at last 6 months before screening visit.
- •Patients should not be on dialysis treatment.
- •Women should not be pregnant, or in fertile period (at last 1 year postmenopausal or chirurgic sterilized or using this contraceptive methods: condoms, gel, intrauterine devices, anticonceptives, etc. During at last 3 months after the study beginning.
排除标准
- •Patients have taken active vitamin D during 6 months after the screening.
- •Patients with allergy o sensibility to paricalcitol.
- •Patients with acute CKD 12 weeks before the screening.
- •Patients with chronical gastrointestinal disease.
- •Patients with hypo or hyperthyroidism.
- •Patients with secondary hypertension
- •Bad controled hypertension patients
- •Patients with renal lithiasis
- •Patients with drug dependence
- •Patients taking calcitonins, biphosphonates, cinacalcet or others Ca-metabolism drugs.
- •Patients taking immunosuppressor drugs.
- •Patients not adequate to study as medical opinion.
- •HIV patients
- •Seric P > 5.0 mg/dl.
- •Seric Ca> 10,0 mg/dl.
- •Proteinuria > 3.500 mg/g
- •Hypoalbuminemia < 3g/dl
研究组 & 干预措施
Daily treatment for CKD
Comparator Arm
干预措施: Comparator Arm (Other)
Paricalcitol, Daily treatment, CKD
Experimental Arm
干预措施: Experimental arm (Drug)
Paricalcitol, Daily treatment, CKD
Experimental Arm
干预措施: Comparator Arm (Other)
结局指标
主要结局
Albuminuria in proteinuric Chronical Kidney Disease patients
时间窗: 1 year
Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit.
次要结局
- Change from baseline albuminuria at 6 months(6 months)