Peroxisome Proliferator-Activated Receptor-Gamma Activation in Peritoneal Dialysis Patients (PPAR)
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ClinicalTrials.gov Identifier: NCT00745225 |
Recruitment Status
:
Completed
First Posted
: September 3, 2008
Last Update Posted
: January 10, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
End-stage Renal Disease | Drug: Pioglitazone Drug: placebo comparator | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
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? |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
---|---|
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
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Placebo Comparator: placebo pill
placebo comparator
|
Drug: placebo comparator
1 capsule daily, 96 weeks.
Other Name: Placebo
|
- Change in carotid intima-media thickness [ Time Frame: wk 48 ]
- 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 ]
- Circulating endothelial progenitor cells [ Time Frame: Week 0, 24, 48 and 96 ]

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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745225
Hong Kong | |
Queen Mary Hospital, Tung Wah Hospital, Pamela Youde Nethersole Eastern Hospital | |
Hong Kong, Hong Kong, 0000 |
Principal Investigator: | Angela YM Wang, MD, FRCP | University of Hong Kong, Queen Mary Hospital |
Responsible Party: | Dr. Angela Yee-Moon Wang, Dr., The University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00745225 History of Changes |
Other Study ID Numbers: |
A111-101 |
First Posted: | September 3, 2008 Key Record Dates |
Last Update Posted: | January 10, 2017 |
Last Verified: | January 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 Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs |