Status:
WITHDRAWN
Thalidomide for the Treatment of Malnutrition Inflammation Syndrome in Peritoneal Dialysis Patients
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Peritoneal Dialysis
Malnutrition
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 c...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00390247
Start Date
January 1 2007
End Date
December 1 2008
Last Update
February 9 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital
Hong Kong, Hong Kong