Clinical trial NCT00516880: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Kidney Diseases
Cardiovascular Diseases
Keywords: chronic kidney disease
cardiovascular disease
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-08-16
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: carotid athersclerosis
timeFrame: 6 month, 1 year and 2 year
measure: endothelial function
timeFrame: 6 month, 1 year and 2 year
Secondary outcomes:
measure: all-cause mortality and cardiovascular event
timeFrame: 1 year, 2 year
measure: pulse wave velocity
timeFrame: 6 month, 1 year, 2 year
measure: inflammation
timeFrame: 6 month, 1 year, 2 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Medicine, Queen Mary Hospital
city: Hong Kong
country: China
facility: Department of Medicine, Tung Wah Hospital
Study officials:
affiliation: Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong
name: Angela Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References: