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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00390247 |
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-), plays a central role in the pathogenesis of the MIA syndrome. Thalidomide selectively inhibits the production of TNF- 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
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.
Condition | Intervention | Phase |
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Peritoneal Dialysis Malnutrition |
Drug: thalidomide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Thalidomide for the Treatment of Malnutrition Inflammation Syndrome in Peritoneal Dialysis Patients: A Randomized Control Trial |
Estimated Enrollment: | 60 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2008 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
evidence of malnutrition:
Exclusion Criteria:
Hong Kong | |
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 |
Study ID Numbers: | CRE-2006.291 |
Study First Received: | October 18, 2006 |
Last Updated: | April 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00390247 |
Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Malnutrition Thalidomide Nutrition Disorders Inflammation |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Angiogenesis Inhibitors |
Pharmacologic Actions Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Leprostatic Agents |