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
  Purpose

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.


Condition Intervention
Chronic Disease
Kidney Diseases
Cardiovascular Diseases
Drug: rosiglitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • carotid athersclerosis [ Time Frame: 6 month, 1 year and 2 year ]
  • endothelial function [ Time Frame: 6 month, 1 year and 2 year ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Study Start Date: March 2006
Estimated Study Completion Date: November 2008
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

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
  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: NCT00516880

Contacts
Contact: Angela Wang, Dr (852) 2855 4949 aw2000_hk@yahoo.com

Locations
China
Department of Medicine, Queen Mary Hospital Recruiting
Hong Kong, China
Sub-Investigator: KN Lai, Prof         
Department of Medicine, Tung Wah Hospital Recruiting
Hong Kong, China
Sub-Investigator: WK Lo, Dr         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
Principal Investigator: Angela Wang, Dr Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00516880     History of Changes
Other Study ID Numbers: UW05-236T/899, HARECCTR0500007
Study First Received: August 15, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
chronic kidney disease
cardiovascular disease

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Kidney Diseases
Atherosclerosis
Arteriosclerosis
Chronic Disease
Calcinosis
Pathologic Processes
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Calcium Metabolism Disorders
Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014