Renal Insufficiency Clinical Trial
Official title:
Effectiveness of Atorvastatin on IL2, IL6, TNFalpha and HLA Levels in the Recipient's Kidney Graft From a Living Donor
Renal insufficiency is a priority disease in the health system, which may require renal
replacement therapy based on kidney transplantation, which is considered as therapy of
choice. During the procedure of kidney transplantation, the body is subjected to
ischemia-reperfusion damage that generates late complications related to graft function.
Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized,
which could be beneficial in kidney transplantation.
Objective: Evaluate the effect of atorvastatin on IL2, IL6, TNFalpha and HLA levels in the
recipient's kidney graft from a living donor.
Material and methods: Controlled, double-blind trial with 12 months follow-up. Composed of 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 and
their recipients. Patients included as donors were randomized into two groups (study or
control) the intervention was implemented 4 weeks before kidney transplant. During surgical
procedure, a biopsy from the recipient's kidney graft was obtained to measure IL-2, IL-6
TNFalpha and HLA by immunohistochemistry, 3 and 12 months after surgery. Recipients kidney
function, surgical complications and kidney graft survival were registered. During surgical
procedure, 3 and 12 months of following, biopsies were obtain to performed histopathological
analysis based on Banff classification of renal allograft rejection grades.
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. Inferential analysis with student's t-test, and/or
Mann-Whitney's U test; chi-square distribution, and/or Fisher's exact test respectively.
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