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Peroxisome Proliferator-Activated Receptor-Gamma Activation in Peritoneal Dialysis Patients (PPAR)

This study is currently recruiting participants.
Verified by The University of Hong Kong, September 2008

Sponsors and Collaborators: The University of Hong Kong
Baxter Healthcare Corporation
GlaxoSmithKline
Information provided by: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00745225
  Purpose

To study whether peroxisome proliferator-activated receptor-gamma activation in peritoneal dialysis patients will reduce inflammation, atherosclerosis, calcification and improve survival of peritoneal dialysis patients


Condition Intervention Phase
End-Stage Renal Disease
Drug: rosiglitazone
Drug: placebo
Phase IV

MedlinePlus related topics:   Kidney Failure   

Drug Information available for:   Rosiglitazone    Rosiglitazone Maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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?

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change in carotid intima-media thickness [ Time Frame: 6 month, 12 month and 24 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in endothelial function, carotid plaque, vascular calcium score, arterial stiffening, abdominal visceral fat, C-reactive protein, HOMA, residual renal function, insulin dosage, overall survival and cardiovascular event-free survival [ Time Frame: at 6 month, 12 month and 24 month ] [ Designated as safety issue: No ]

Estimated Enrollment:   160
Study Start Date:   February 2006
Estimated Study Completion Date:   September 2011
Estimated Primary Completion Date:   September 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
rosiglitazone
Drug: rosiglitazone
oral rosiglitazone 4mg daily for 12 weeks, then 4mg BD for 84 weeks
2: Placebo Comparator
placebo
Drug: placebo

Detailed Description:

Peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality and are related to the presence of accelerated atherosclerosis. Other than the traditional cardiovascular risk factors, there is increasing evidence that inflammation is associated with the development of atherosclerosis and cardiovascular events in both the general and dialysis population. C-reactive protein is predictive of higher all-cause mortality and cardiovascular mortality, independent of other cardiovascular risk factors and atherosclerotic vascular disease. As a considerable proportion of peritoneal dialysis patients showed elevated C-reactive protein, it raises an important question as to whether lowering C-reactive protein will have any cardiovascular and survival benefit in these patients. On the other hand, insulin resistance with associated hyperinsulinemia is frequently observed in chronic renal failure and dialysis patients. Although the exact mechanism of insulin resistance needs further evaluation, studies indicated that insulin resistance is an important cardiovascular risk factor and outcome predictor in the general and dialysis population. Moreover, recent evidence indicates an association between chronic inflammation and insulin resistance although the exact interrelationship remains unclear. The peroxisome proliferator-activated receptor-gamma (PPAR-g) is a member of the nuclear receptor family of ligand-dependent transcription factors. PPAR-g is highly expressed in adipose tissue and clinical study has confirmed efficacy of the specific ligands for PPAR-gamma, namely thiazolidinediones (TZD), in improving insulin sensitivity. Recent experimental and clinical studies demonstrated that TZD has anti-inflammatory and anti-atherosclerotic properties other than insulin sensitizing effect in type 2 diabetics. We hypothesize that modulation of the PPAR-g activity may be a novel therapeutic strategy for reducing inflammation and improving insulin sensitivity and may retard the progression of atherosclerosis and possibly reduce mortality of our peritoneal dialysis patients.

  Eligibility
Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Both prevalent patients or patients newly started on continuous peritoneal dialysis, with or without diabetes mellitus will be considered eligible for study entry.
  • For patients newly started on chronic peritoneal dialysis, they will be suitable for recruitment into the study after one month on peritoneal dialysis.
  • Patients who provide informed consent for the study

Exclusion Criteria:

  • Patients with underlying active malignancy
  • Patients with chronic liver disease or liver cirrhosis
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745225

Contacts
Contact: Angela YM Wang, MD, FRCP     852-28554949     aymwang@hku.hk    

Locations
Hong Kong
Queen Mary Hospital, Tung Wah Hospital, Pamela Youde Nethersole Eastern Hospital     Recruiting
      Hong Kong, Hong Kong, 0000
      Contact: Angela YM Wang, MD, FRCP     28554949     aymwang@hku.hk    

Sponsors and Collaborators
The University of Hong Kong
Baxter Healthcare Corporation
GlaxoSmithKline

Investigators
Principal Investigator:     Angela YM Wang, MD, FRCP     University of Hong Kong, Queen Mary Hospital    
  More Information


Responsible Party:   Queen Mary Hospital, University of Hong Kong ( Dr Wang Angela Yee-Moon )
Study ID Numbers:   A111-101
First Received:   September 1, 2008
Last Updated:   September 2, 2008
ClinicalTrials.gov Identifier:   NCT00745225
Health Authority:   Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
peritoneal dialysis, cardiovascular, PPAR-gamma  

Study placed in the following topic categories:
Atherosclerosis
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Rosiglitazone
Kidney Failure
Inflammation

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008




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