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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?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00516880
Enrollment
160
Registered
2007-08-16
Start date
2006-03-31
Completion date
2008-11-30
Last updated
2010-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Chronic Disease, Kidney Diseases

Keywords

chronic kidney disease, cardiovascular disease

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.

Interventions

DRUGrosiglitazone

Sponsors

Hospital Authority, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frame
carotid athersclerosis6 month, 1 year and 2 year
endothelial function6 month, 1 year and 2 year

Secondary

MeasureTime frame
all-cause mortality and cardiovascular event1 year, 2 year
pulse wave velocity6 month, 1 year, 2 year
inflammation6 month, 1 year, 2 year

Countries

China

Contacts

Primary ContactAngela Wang, Dr
aw2000_hk@yahoo.com(852) 2855 4949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026