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Clinical Trial Details

Trial ID: L0945
Source ID: NCT00745225
Associated Drug: Pioglitazone
Title: Peroxisome Proliferator-Activated Receptor-Gamma Activation in Peritoneal Dialysis Patients
Acronym: PPAR
Status: COMPLETED
Study Results: NO
Results:
Conditions: End-stage Renal Disease
Interventions: DRUG: Pioglitazone|DRUG: placebo comparator
Outcome Measures: Primary: Change in carotid intima-media thickness, Change in carotid intima-media thickness, over 48 weeks|change in flow mediated dilatation (marker of endothelial function), change in flow mediated dilatation (marker of endothelial function), over 48 weeks | Secondary: change in aortic pulse wave velocity, change in aortic pulse wave velocity, over 96 weeks|change in augmentation index-heart rate adjusted, change in augmentation index-heart rate adjusted, over 96 weeks|change in nitroglycerin-mediated dilatation, change in nitroglycerin-mediated dilatation, over 48 weeks|change in coronary artery calcium score, change in coronary artery calcium score, over 96 weeks|change in heart valves calcium score, change in heart valves calcium score, over 96 weeks|change in carotid artery calcium score, change in carotid artery calcium score, over 96 weeks|change in abdominal visceral fat, change in abdominal visceral fat, over 96 weeks|change in subcutaneous fat, change in subcutaneous fat, over 96 weeks|change in blood pressure, change in blood pressure, over 96 weeks|change in C-reactive protein, change in C-reactive protein, over 96 weeks|change in residual kidney function, change in residual kidney function, over 96 weeks|change in HOMA index (among those not on insulin), Change in insulin resistance index, over 96 weeks|change in D/P creatinine ratio, Change in peritoneal solute transport parameter, over 96 weeks|change in peritoneal ultrafiltration with 2.5% during PET, Change in peritoneal ultrafiltration volume, over 96 weeks|change in handgrip strength, change in handgrip strength, over 96 weeks|Change in cardiac biomarkers, change in cardiac biomarkers, over 96 weeks|change in insulin dose (among those on insulin), change in insulin dose, over 96 weeks|change in endothelial progenitor cells, change in endothelial progenitor cells, over 96 weeks|change in central systolic blood pressure, change in central systolic blood pressure, over 96 weeks|Change in central diastolic blood pressure, change in central diastolic blood pressure, over 96 weeks|change in glycemic control (fasting glucose, and glycosylated hemoglobin), change in glycemic control, over 96 weeks | Other: overall survival, Hard outcome, over 96 weeks|major adverse cardiovascular event-free survival, hard outcome, over 96 weeks|Fluid overload/heart failure event-free survival, hard outcome, over 96 weeks|myocardial infarction event-free survival, hard outcome, over 96 weeks|3 point major adverse cardiovascular event-free survival, Hard outcome, over 96 weeks|4 point major adverse cardiovascular event-free survival, Hard outcome, over 96 weeks
Sponsor/Collaborators: Sponsor: The University of Hong Kong | Collaborators: Baxter Healthcare Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 160
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2006-02
Completion Date: 2014-12
Results First Posted:
Last Update Posted: 2021-10-08
Locations: Queen Mary Hospital, Tung Wah Hospital, Hong Kong, 0000, Hong Kong
URL: https://clinicaltrials.gov/show/NCT00745225