Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02522117
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2015-08-07
Brief Title:
Atorvastatin in the Recipients Kidney Graft From a Living Donor
Sponsor:
Instituto Mexicano del Seguro Social
Organization:
Instituto Mexicano del Seguro Social
Study Overview
Official Title:
Effectiveness of Atorvastatin on IL2 IL6 TNFalpha and HLA Levels in the Recipients Kidney Graft From a Living Donor
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATORV15
Brief Summary:
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
Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized which could be beneficial in kidney transplantation
Detailed Description:
Objective Evaluate the effect of atorvastatin on IL2 IL6 TNFalpha and HLA levels in the recipients 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 recipients 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 students t-test andor Mann-Whitneys U test chi-square distribution andor Fishers exact test respectively
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 recipients 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 students t-test andor Mann-Whitneys U test chi-square distribution andor Fishers exact test respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None