Back to resultsTargeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?
Primary Purpose
Chronic Disease, Kidney Diseases, Cardiovascular Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rosiglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease focused on measuring chronic kidney disease, cardiovascular disease
Eligibility 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
Sites / Locations
- Department of Medicine, Queen Mary HospitalRecruiting
- Department of Medicine, Tung Wah HospitalRecruiting
Outcomes
Primary Outcome Measures
carotid athersclerosis
endothelial function
Secondary Outcome Measures
all-cause mortality and cardiovascular event
pulse wave velocity
inflammation
Full Information
NCT ID
NCT00516880
First Posted
August 15, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00516880
Brief Title
Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?
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?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Kidney Diseases, Cardiovascular Diseases
Keywords
chronic kidney disease, cardiovascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rosiglitazone
Primary Outcome Measure Information:
Title
carotid athersclerosis
Time Frame
6 month, 1 year and 2 year
Title
endothelial function
Time Frame
6 month, 1 year and 2 year
Secondary Outcome Measure Information:
Title
all-cause mortality and cardiovascular event
Time Frame
1 year, 2 year
Title
pulse wave velocity
Time Frame
6 month, 1 year, 2 year
Title
inflammation
Time Frame
6 month, 1 year, 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Wang, Dr
Phone
(852) 2855 4949
Email
aw2000_hk@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Wang, Dr
Organizational Affiliation
Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Queen Mary Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KN Lai, Prof
Facility Name
Department of Medicine, Tung Wah Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WK Lo, Dr
12. IPD Sharing Statement
Learn more about this trial
Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?
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