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

This study has suspended participant recruitment.
(Fail of applying funding)
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00390247
First received: October 18, 2006
Last updated: April 5, 2007
Last verified: April 2007
  Purpose

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

  • 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 Intervention Phase
Peritoneal Dialysis
Malnutrition
Drug: thalidomide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Thalidomide for the Treatment of Malnutrition Inflammation Syndrome in Peritoneal Dialysis Patients: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Nutritional status

Secondary Outcome Measures:
  •  Change in arterial pulse wave velocity
  •  Total number of days of hospital admission during study period
  •  Composite cardiovascular end point

Estimated Enrollment: 60
Study Start Date: January 2007
Estimated Study Completion Date: December 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically stable adult patients (18 to 80 years old) on PD; and
  • evidence of malnutrition:

    1. overall subjective global assessment score  5; or
    2. malnutrition inflammation score  9; or
    3. serum albumin  35 g/L
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390247

Locations
Hong Kong
Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Cheuk-Chun Szeto, MD Chinese University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00390247     History of Changes
Other Study ID Numbers: CRE-2006.291
Study First Received: October 18, 2006
Last Updated: April 5, 2007
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Inflammation
Malnutrition
Nutrition Disorders
Pathologic Processes
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014