Atorvastatin in the Recipient's Kidney Graft From a Living Donor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Atorvastatin on IL2, IL6, TNFalpha and HLA Levels in the Recipient's Kidney Graft From a Living Donor

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Donors Inclusion Criteria: Accepted as kidney donor Voluntary participation Informed consent accepted 85% fulfillment of atorvastatin treatment Entitlement to the Mexican Institute of Social Security Donors Exclusion Criteria: Hypersensibility to Atorvastatin Smoking Recipients Inclusion Criteria: Accepted as kidney recipient Entitlement to the Mexican Institute of Social Security Recipients Exclusion Criteria: Patients who dropped out from study or withdrew the informed consent Insufficient kidney biopsy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br>24 patients received oral atorvastatin 40 mg once a day, for 4 weeks. | Drug: Atorvastatin<br>* 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 transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient's kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.<br>* Other names: Lipitor;|
| Placebo Comparator: Placebo<br>24 patients received oral placebo 40 mg once a day, for 4 weeks. | Drug: Placebo<br>* 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 transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient's kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.<br>* Other names: Homologated placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HLA levels in the kidney graft biopsy | HLA levels were measure by immunohistochemistry, observing alteration between groups. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | In a blood sample and in a urine 24-hour collection, serum creatinine, serum urea, creatinine clearance, urine output, and proteinuria were measure. Differences in evolution and alteration between the 2 groups were registered. | 12 months | 
| Kidney graft survival | In a renal biopsy using the Banff classification of renal allograft rejection grades, were assessed histologic and molecular features by microscopy and immunofluorescence. Alterations between groups were registered. | 12 months | 
| Surgery complications | During surgical procedure and following, any kind of complication was registered. | 12 months | 
| TNFalpha levels in the kidney graft biopsy | TNFalpha levels were measure by immunohistochemistry, observing alteration between groups. | 12 months | 
| IL2 and IL6 levels in the kidney graft biopsy | IL2 and IL6 levels were measure by immunohistochemistry, observing alteration between groups. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, Atorvastatin, Human Leukocyte Antigens, Interleukin