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Thalidomide for the Treatment of Malnutrition Inflammation Syndrome in Peritoneal Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390247
Recruitment Status : Withdrawn (Fail of applying funding)
First Posted : October 19, 2006
Last Update Posted : February 9, 2016
Information provided by:
Chinese University of Hong Kong

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis Malnutrition Drug: thalidomide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Thalidomide for the Treatment of Malnutrition Inflammation Syndrome in Peritoneal Dialysis Patients: A Randomized Control Trial
Study Start Date : January 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Primary Outcome Measures :
  1. Nutritional status [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in arterial pulse wave velocity [ Time Frame: 12 months ]
  2. Total number of days of hospital admission during study period [ Time Frame: 12 months ]
  3. Composite cardiovascular end point [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

A. clinically stable adult patients (18 to 80 years old) on PD; and

B. evidence of malnutrition:

  1. overall subjective global assessment score < 5; or
  2. malnutrition inflammation score > 9; or
  3. serum albumin < 35 g/L C. written patient informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390247

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Hong Kong
Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Cheuk-Chun Szeto, MD Chinese University of Hong Kong
Layout table for additonal information Identifier: NCT00390247    
Other Study ID Numbers: CRE-2006.291
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: April 2007
Additional relevant MeSH terms:
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Pathologic Processes
Nutrition Disorders
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents