Thalidomide for the Treatment of Malnutrition Inflammation Syndrome in Peritoneal Dialysis Patients
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.
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.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Thalidomide for the Treatment of Malnutrition Inflammation Syndrome in Peritoneal Dialysis Patients: A Randomized Control Trial|
- Nutritional status [ Time Frame: 12 months ]
- Change in arterial pulse wave velocity [ Time Frame: 12 months ]
- Total number of days of hospital admission during study period [ Time Frame: 12 months ]
- Composite cardiovascular end point [ Time Frame: 12 months ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||December 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390247
|Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Cheuk-Chun Szeto, MD||Chinese University of Hong Kong|