Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
Information source: Instituto Mexicano del Seguro Social
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Insufficiency
Intervention: Atorvastatin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Instituto Mexicano del Seguro Social Official(s) and/or principal investigator(s): Clotilde Fuentes-Orozco, PhD, Study Director, Affiliation: Instituto Mexicano del Seguro Social
Summary
Renal Insufficiency is a priority disease in health system, which may require renal
replacement therapy based on renal transplantation, which is considered as therapy of
choice. During the procedure of renal transplantation, the graft could be damaged by
ischemia-reperfusion which generates complications in its function.
Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized,
which could be beneficial in renal transplantation.
Clinical Details
Official title: Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: C-Reactive Protein evolution in donorsKidney graft rejection using scale of BANFF
Secondary outcome: Kidney function evolution after transplantInterleukin and tumor necrosis factor alpha. Complications
Detailed description:
Objective: Evaluate anti-inflammatory effect of atorvastatin on renal graft in living donor
transplantation.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Accepted as kidney donor
- Voluntary participation
- Informed consent accepted
- 85% fulfillment of atorvastatin treatment
Exclusion Criteria:
- Hypersensibility to Atorvastatin
- Smoking
Locations and Contacts
Western Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco 44340, Mexico
Additional Information
Starting date: January 2012
Last updated: January 30, 2015
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