Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
NCT ID: NCT02355704
Last Updated: 2015-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
48 participants
INTERVENTIONAL
2012-01-31
2014-07-31
Brief Summary
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Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.
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Detailed Description
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Material and methods: Controlled, double-blind clinical trial with posterior following for 12 months. Composed by 48 patients, randomized manner, realized at the Transplant Department of Western Medical Center, Mexican Institute of Social Security. Universe was patients accepted as kidney donors. Patients were randomized in two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. Previous surgical procedure, in a blood sample, C-Reactive Protein (C-RP) and laboratory control were measured. During surgical procedure, a biopsy was obtained to measure IL-6 and tumoral necrosis factor alpha by immunohistochemistry. 24 hours after surgical procedure, 3 and 12 months of following, kidney function, complications and graft survival were registered. During surgical procedure, 3 months and 12 months of following, biopsies were obtain to performed histopathological analysis of scale of Banff
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atorvastatin
22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks
Atorvastatin
Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure controls were performed
Placebo
22 patients received oral placebo 40 mg 1 time for day for 4 weeks
Placebo
Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure were performed
Interventions
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Atorvastatin
Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure controls were performed
Placebo
Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure were performed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Voluntary participation
* Informed consent accepted
* 85% fulfillment of atorvastatin treatment
Exclusion Criteria
* Smoking
18 Years
ALL
Yes
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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CLOTILDE FUENTES OROZCO
PhD
Principal Investigators
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Clotilde Fuentes-Orozco, PhD
Role: STUDY_DIRECTOR
Instituto Mexicano del Seguro Social
Locations
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Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, Mexico
Countries
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Other Identifiers
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2011-1301-78
Identifier Type: -
Identifier Source: org_study_id
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