CClinicalTrials.gg
Status unknownNCT00516880Updated Jul 7, 2010

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

An interventional study of rosiglitazone in Chronic Disease, Kidney Diseases and Cardiovascular Diseases, sponsored by Hospital Authority, Hong Kong. Status unknown at 2 sites in China. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-07-07.

Sponsored by Hospital Authority, Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Disease
  • Kidney Diseases
  • Cardiovascular Diseases

Keywords

  • chronic kidney disease
  • cardiovascular disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 160 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Hospital Authority, Hong Kong is the lead sponsor of 73 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
160 participants (estimated)

Interventions

  • Drugrosiglitazone
06

What researchers measure

Primary outcomes

  1. carotid athersclerosis

    Time frame: 6 month, 1 year and 2 year

  2. endothelial function

    Time frame: 6 month, 1 year and 2 year

Secondary outcomes

  1. all-cause mortality and cardiovascular event

    Time frame: 1 year, 2 year

  2. pulse wave velocity

    Time frame: 6 month, 1 year, 2 year

  3. inflammation

    Time frame: 6 month, 1 year, 2 year

07

Study locations

2 of 2 sites recruiting
  • Department of Medicine, Queen Mary Hospital
    Hong Kong, China
    • KN Lai, Prof · Sub investigator
    Recruiting
  • Department of Medicine, Tung Wah Hospital
    Hong Kong, China
    • WK Lo, Dr · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00516880
Lead sponsor
Hospital Authority, Hong Kong
First posted
Aug 16, 2007
Start date
Mar 2006
Completion
Nov 2008 (estimated)
Last update
Jul 7, 2010

Study contacts

Angela Wang, Dr
Contact
aw2000_hk@yahoo.com
(852) 2855 4949
Angela Wang, Dr
principal investigator · Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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