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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01258322 |
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Date of registration:
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09/12/2010 |
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Primary sponsor: |
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Public title:
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Pioglitazone Attenuates Dysmetabolism in Peritoneal Dialysis (PD) Patients
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Scientific title:
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Twelve Weeks of Pioglitazone Therapy Significantly Attenuates Dysmetabolism and Reduces Inflammation in Prevalent Peritoneal Dialysis Patients. A Randomized, Cross-over Trial. |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01258322 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Tongying Zhu, MD and PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Huashan Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
All patients received more than one month regular continuous ambulatory peritoneal
dialysis(CAPD) or intermittent peritoneal dialysis(IPD). The causes of chronic renal
failure were diabetes and non-diabetes.-
Exclusion Criteria:
history of allergy to thiazolidinediones and fenofibrate; history of any sever adverse
event for fibrate that can't be tolerated by the patients; patient can not be follow-up
regularly; history of myocardial infarction(MI) or coronary artery bypass graft (CABG)
surgery within the past 1 month, history of cerebral vascular accident (CVA) or
percutaneous transluminal coronary angioplasty(PTCA) within the past 6 months; chronic use
of non-steroidal anti-inflammatory drugs(NSAIDs), steroids or immunosuppressives; patient
with the acute infection; patient with malignant tumor; have the evidence of severe
hepatic injury (ALT/AST>100u/L).-
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertriglyceridemia
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Inflammation
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Insulin Resistance
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Peritoneal Dialysis
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Pioglitazone
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Intervention(s)
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Drug: Pioglitazone
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Primary Outcome(s)
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change of serum TG level
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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the change of serum CHO, LDL. HDL level, HOMA-IR, adipocytokines level and CRP
[Time Frame: 12 weeks]
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Secondary ID(s)
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Neph-1000
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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