Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?
2 other identifiers
interventional
160
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2006
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 15, 2007
CompletedFirst Posted
Study publicly available on registry
August 16, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedJuly 7, 2010
July 1, 2010
August 15, 2007
July 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
carotid athersclerosis
6 month, 1 year and 2 year
endothelial function
6 month, 1 year and 2 year
Secondary Outcomes (3)
all-cause mortality and cardiovascular event
1 year, 2 year
pulse wave velocity
6 month, 1 year, 2 year
inflammation
6 month, 1 year, 2 year
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Medicine, Queen Mary Hospital
Hong Kong, China
Department of Medicine, Tung Wah Hospital
Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Wang, Dr
Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
August 15, 2007
First Posted
August 16, 2007
Study Start
March 1, 2006
Study Completion
November 1, 2008
Last Updated
July 7, 2010
Record last verified: 2010-07