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

This study has been completed.
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Dr. Angela Yee-Moon Wang, The University of Hong Kong Identifier:
First received: September 1, 2008
Last updated: January 7, 2017
Last verified: January 2017
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: Pioglitazone Drug: placebo comparator Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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?

Resource links provided by NLM:

Further study details as provided by Dr. Angela Yee-Moon Wang, The University of Hong Kong:

Primary Outcome Measures:
  • Change in carotid intima-media thickness [ Time Frame: wk 48 ]

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 wk 24, wk 48 and wk 96 ]
  • carotid intima-media thickness [ Time Frame: Wk 24 and wk 96 ]

Other Outcome Measures:
  • Circulating endothelial progenitor cells [ Time Frame: Week 0, 24, 48 and 96 ]

Enrollment: 160
Study Start Date: February 2006
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active intervention arm
Peroxisome proliferator activator receptor gamma treatment, Pioglitazone
Drug: Pioglitazone
pioglitazone 15mg daily for 12 weeks, then 30mg daily for 84 weeks
Other Name: Actos
Placebo Comparator: placebo pill
placebo comparator
Drug: placebo comparator
1 capsule daily, 96 weeks.
Other Name: 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.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00745225

Hong Kong
Queen Mary Hospital, Tung Wah Hospital, Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong, 0000
Sponsors and Collaborators
The University of Hong Kong
Baxter Healthcare Corporation
Principal Investigator: Angela YM Wang, MD, FRCP University of Hong Kong, Queen Mary Hospital
  More Information

Responsible Party: Dr. Angela Yee-Moon Wang, Dr., The University of Hong Kong Identifier: NCT00745225     History of Changes
Other Study ID Numbers: A111-101
Study First Received: September 1, 2008
Last Updated: January 7, 2017

Keywords provided by Dr. Angela Yee-Moon Wang, The University of Hong Kong:
peritoneal dialysis, cardiovascular, PPAR-gamma

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 21, 2017