Paricalcitol Action on Parameters of Inflammation and Oxidative Stress in Patients With Chronic Kidney Disease Stage Vd Carriers Tunneled Hemodialysis Catheters
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment
研究概览
简要总结
Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.
详细描述
Use of Paricalcitol in stage Vd Chronic Kidney Disease patients using a permanent catheter due to haemodialysis; over the effect of inflammatory and oxidative stress parameters. This study uses paricalcitol (vitamin D) versus atorvastatin versus paricalcitol plus atorvastatin treatments.
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
- Single (Participant)
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
- •Vd CKD patients using haemodialysis during 3 or more months.
- •Tunnelized-bearer permanent catheters on haemodialysis at last 6 months previous at the beginning of the study. .
- •Kt stable, over 45 litres on both sexs.
- •Patients in treatment wiht atorvastatin
- •Patients without infectious or inflammatory processes over 8 weeks.
- •Two consecutive PTH < than 400 pg/ml; Ca<10.2 and P <7.0 mg/dl.
排除标准
- •Patients > 18 years.
- •Pregnant women.
- •Patients hospitalized 4 weeks before the beginning of the treatment.
- •Immunosuppressor intake.
研究组 & 干预措施
Paricalcitol
SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.
干预措施: Paricalcitol (Drug)
Paricalcitol, Atorvastatin
SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)
干预措施: Paricalcitol, atorvastatin (Drug)
Atorvastatin
SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment
时间窗: 12 weeks of treatment wiht visits and analysis
Measure parameter: IL-2
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
时间窗: 12 weeks of treatment with visits and analysis
FGF-23
Oxidative stress and inflammative parameters
时间窗: 12 weeks of treatment
Measure unit: IL-4
次要结局
- Anaemia parameters(12 weeks of treatment)
- Anaemia Parameters(12 weeks of treatment)
- Nutritional Parameters(12 weeks of treatment with visits and analysis)
- Erythropoietin requirements variations(12 weeks of treatment with visits and analysis)
- Erythropoietin requirement variations(12 weeks of treatment with visits and analysis)
- Assess potential benefits inflammatory markers(12 weeks of treatment with visits and analysis)
- Assess potential benefits in inflammatory markers(16 weeks, the complete duration of the study)
研究者
Ricardo Mouzo Mirco
MD
Hospital El Bierzo