Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?

Cardiovascular Diseases Clinical Trial

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00516880
• Other study ID #: UW05-236T/899
• Secondary ID: HARECCTR0500007
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2007
• Last updated: July 6, 2010
• Start date: March 2006
• Est. completion date: November 2008

Study information

• Verified date: July 2010
• Source: Hospital Authority, Hong Kong
• Contact: Angela Wang, Dr
• Phone: (852) 2855 4949
• Email: aw2000_hk[@]yahoo.com
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 2008
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Calcinosis
• Cardiovascular Diseases
• Chronic Disease
• Kidney Diseases

Intervention

Drug:
• rosiglitazone

Locations

Country	Name	City	State
China	Department of Medicine, Queen Mary Hospital	Hong Kong
China	Department of Medicine, Tung Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	carotid athersclerosis		6 month, 1 year and 2 year
Primary	endothelial function		6 month, 1 year and 2 year
Secondary	all-cause mortality and cardiovascular event		1 year, 2 year
Secondary	pulse wave velocity		6 month, 1 year, 2 year
Secondary	inflammation		6 month, 1 year, 2 year

External Links

•   HAREC Clinical Trial Registry