Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- Catalysis SL
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Body mass index (BMI) at week 72 (end of the treatment)
研究概览
简要总结
The purpose of the study is to determine whether Viusid administration improves malnutrition, atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects with Chronic Inflammatory Syndrome under hemodialysis treatment. The duration of this double-blind placebo controlled phase 3 clinical trial will be 60 weeks. All patients enrolled in the study will be receiving the standard treatment for Chronic Inflammatory Syndrome including hemodialysis and administration of a hypercaloric and hyperproteic diet. Efficacy assessment will be carried out 12 weeks after the end of Viusid or placebo treatment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects with chronic terminal nephropathy under hemodialysis treatment for at least 3 months
- •Signed informed consent
排除标准
- •Patients with chronic terminal nephropathy previously treated with peritoneal dialysis
- •Receptors of a renal graft
- •Patients with malignant neoplastic conditions
- •Pregnant women
结局指标
主要结局
Body mass index (BMI) at week 72 (end of the treatment)
时间窗: 72 weeks
Carotidal Doppler at week 72 (end of the treatment)
时间窗: 72 weeks
C reactive protein at weeks 72 (end of the treatment)
时间窗: 72 weeks
Hemoglobin at week 72 (end of the treatment)
时间窗: 72 weeks
次要结局
- Cholesterol at week 72(72 weeks)
- Triglycerides at week 72(72 weeks)
- Frequency of infection episodes at week 72(72 weeks)
- Creatinine at week 72(72 weeks)
- Uric acid at week 72(72 weeks)
- Glutamic-pyruvic transaminase (GPT)at week 72(72 weeks)
- Glutamic-oxaloacetic transaminase (GOT)at week 72(72 weeks)
- Blood glucose concentrations at week 72(72 weeks)
- Gasometry at week 72(72 weeks)
- Adverse effects at week 72(72 weeks)
- Albumin at week 72(72 weeks)
- KTV at week 72(72 weeks)
- Phosphocalcic metabolism at week 72(72 weeks)
- Hematocrit at week 72(72 weeks)