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Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00516880
First received: August 15, 2007
Last updated: July 6, 2010
Last verified: July 2010

August 15, 2007
July 6, 2010
March 2006
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  • carotid athersclerosis [ Time Frame: 6 month, 1 year and 2 year ]
  • endothelial function [ Time Frame: 6 month, 1 year and 2 year ]
Same as current
Complete list of historical versions of study NCT00516880 on ClinicalTrials.gov Archive Site
  • all-cause mortality and cardiovascular event [ Time Frame: 1 year, 2 year ]
  • pulse wave velocity [ Time Frame: 6 month, 1 year, 2 year ]
  • inflammation [ Time Frame: 6 month, 1 year, 2 year ]
Same as current
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Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?
Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?

Peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality and are related to the presence of accelerated atherosclerosis. Our recent data showed that inflammation predicts mortality and cardiovascular death, independent of other cardiovascular risk factors in peritoneal dialysis patients. As a considerable proportion of peritoneal dialysis patients showed evidence of inflammation, it raises an important question as to whether anti-inflammatory treatment has any cardiovascular and survival benefit in these patients. The peroxisome proliferator-activated receptor-gamma (PPAR-g) agonist is a class of drug with insulin sensitizing property. Recent experimental and clinical studies demonstrated that this class of drug has anti-inflammatory and anti-atherosclerotic properties other than insulin sensitizing effect in type 2 diabetics. We therefore hypothesize that modulation of the PPAR-g activity may be a novel therapeutic strategy for reducing inflammation and retarding the progression of atherosclerosis and possibly lowering mortality in our peritoneal dialysis patients.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Chronic Disease
  • Kidney Diseases
  • Cardiovascular Diseases
Drug: rosiglitazone
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
November 2008
Not Provided

Inclusion Criteria:

  • Both prevalent patients or patients newly started on continuous ambulatory peritoneal dialysis with age between 20 - 75 with or without diabetes mellitus will be considered eligible for study entry. For patients newly started on continuous ambulatory peritoneal dialysis, they will be suitable for recruitment into the study after one month on continuous ambulatory peritoneal dialysis.

Exclusion Criteria:

  • Patients with underlying malignancy
  • Patients with chronic liver disease or liver cirrhosis
  • Patients with hepatitis B or C positive
  • Patients with active infections
  • Patients with other chronic active inflammatory disease such as systemic lupus erythematosus, rheumatoid arthritis
  • Patients who refuse study participation
  • Patients with underlying congenital heart disease or rheumatic heart disease
  • Patients with poor general condition
  • Patients with plans for living related kidney transplant within 2 years
  • Female patients with pregnancy
  • Patients with history of recurrent hypoglycemia
  • Patients with Class III and IV congestive heart failure
  • Patients already receiving glitazones treatment at the screening visit
Both
20 Years to 75 Years
Not Provided
Contact: Angela Wang, Dr (852) 2855 4949 aw2000_hk@yahoo.com
China
 
NCT00516880
UW05-236T/899, HARECCTR0500007
Not Provided
Not Provided
Hospital Authority, Hong Kong
Not Provided
Principal Investigator: Angela Wang, Dr Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong
Hospital Authority, Hong Kong
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP