|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | The University of Hong Kong |
|---|---|
| Collaborator: |
Baxter Healthcare Corporation |
| Information provided by (Responsible Party): | 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: Pioglitazone Drug: placebo comparator |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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? |
| Estimated Enrollment: | 160 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Angela YM Wang, MD, PhD | 852-22554949 | aymwang@hku.hk |
| Hong Kong | |
| Queen Mary Hospital, Tung Wah Hospital, Pamela Youde Nethersole Eastern Hospital | Recruiting |
| Hong Kong, Hong Kong, 0000 | |
| Contact: Angela YM Wang, MD, PhD 22554949 aymwang@hku.hk | |
| Principal Investigator: | Angela YM Wang, MD, FRCP | University of Hong Kong, Queen Mary Hospital |
More Information
| Responsible Party: | The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00745225 History of Changes |
| Other Study ID Numbers: | A111-101 |
| Study First Received: | September 1, 2008 |
| Last Updated: | October 4, 2011 |
| Health Authority: | Hong Kong: Ethics Committee |
|
peritoneal dialysis, cardiovascular, PPAR-gamma |
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |