Thalidomide for the Treatment of Malnutrition Inflammation Syndrome in Peritoneal Dialysis Patients: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Nutritional status
研究概览
简要总结
Hypothesis In peritoneal dialysis (PD) patients, malnutrition, inflammation and atherosclerotic cardiovascular disease commonly coexist. The triad has been coined the "MIA syndrome". Proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-alpha), plays a central role in the pathogenesis of the MIA syndrome. Thalidomide selectively inhibits the production of TNF-alpha and represents a valuable anti-cytokine therapy.
Specific Aim To study the effect of thalidomide in attenuating or reversing malnutrition and systemic inflammation in PD patients.
Research Plan
Design: Double-blinded randomised prospective placebo control trial. Setting: Renal unit of a university teaching hospital. Subjects: Sixty prevalent PD patients with evidence of malnutrition. Interventions: Patients will be randomised to receive either oral thalidomide 100 mg nocte or placebo.
Main outcome measures: Patients will be followed for 1 year. Nutritional parameters including serum albumin, subjective global assessment, malnutrition-inflammation score, normalised protein nitrogen appearance, fat-free edema-free body mass and anthropometry measurements will be monitored. Systemic inflammatory markers such as serum C-reactive protein and IL-6 will be assayed. Hospitalisation, cardiovascular events, and overall patient survival will also be compared during study period.
Expected Outcome
Nutritional parameters and markers of systemic inflammation are expected to improve with thalidomide therapy. The magnitude of improvement in nutrition, as well as patient morbidity, will be compared with placebo.
In Hong Kong, 80% of end-stage renal failure patients are treated with PD. Malnutrition, cardiovascular disease and systemic inflammatory response are all common in our clinical practice. They are major causes of patient morbidity and mortality. As a readily available anti-cytokine therapy, thalidomide may represent a valuable treatment of the MIA syndrome. The proposed study will provide important insight on the clinical benefit of thalidomide treatment in malnourished PD patients, which accounts for about one-third of our dialysis population.
详细描述
Overall study design
This is a single-center randomized placebo control study on 60 prevalent PD patients.
Recruitment phase will take up to 12 months, and the study phase will be 1 year. Study code will only be revealed at the end of the study period or if patients develop serious adverse reactions.
Patient selection
A randomized prospective study will be performed in 60 stable PD patients. Recruitment criteria are:
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. clinically stable adult patients (18 to 80 years old) on PD; and
- •B. evidence of malnutrition:
- •overall subjective global assessment score < 5; or
- •malnutrition inflammation score > 9; or
- •serum albumin < 35 g/L C. written patient informed consent
排除标准
- •Patients who are planned to have elective living donor transplant within 6 months Patients who are planned to transfer to other renal center within 6 months High likelihood of early withdrawal from the study (e.g. myocardial infarction, severe or unstable coronary disease, stroke, severe liver disease within 3 months) Active infection or systemic inflammatory disease. Current malignant disease Pregnancy or breast-feeding Women of childbearing potential with unreliable birth control methods Known hypersensitivity to thalidomide
结局指标
主要结局
Nutritional status
时间窗: 12 months
次要结局
- Composite cardiovascular end point(12 months)
- Change in arterial pulse wave velocity(12 months)
- Total number of days of hospital admission during study period(12 months)