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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00745225
First received: September 1, 2008
Last updated: June 19, 2013
Last verified: June 2013

September 1, 2008
June 19, 2013
February 2006
October 2014   (final data collection date for primary outcome measure)
Change in carotid intima-media thickness [ Time Frame: wk 48 ] [ Designated as safety issue: No ]
Change in carotid intima-media thickness [ Time Frame: 6 month, 12 month and 24 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00745225 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • carotid intima-media thickness [ Time Frame: Wk 24 and wk 96 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Peroxisome Proliferator-Activated Receptor-Gamma Activation in 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?

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
End-stage Renal Disease
  • Drug: Pioglitazone
    pioglitazone 15mg daily for 12 weeks, then 30mg daily for 84 weeks
    Other Name: Actos
  • Drug: placebo comparator
    1 capsule daily, 96 weeks.
  • Experimental: Active intervention arm
    Peroxisome proliferator activator receptor gamma treatment, Pioglitazone
    Intervention: Drug: Pioglitazone
  • Placebo Comparator: placebo pill
    placebo comparator
    Intervention: Drug: placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00745225
A111-101
Yes
The University of Hong Kong
The University of Hong Kong
Baxter Healthcare Corporation
Principal Investigator: Angela YM Wang, MD, FRCP University of Hong Kong, Queen Mary Hospital
The University of Hong Kong
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP