Clinical trial NCT02522117: Atorvastatin in the Recipient's Kidney Graft From a Living Donor
Official title: Effectiveness of Atorvastatin on IL2, IL6, TNFalpha and HLA Levels in the Recipient's Kidney Graft From a Living Donor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Insufficiency
Keywords: Kidney Transplantation
Atorvastatin
Human Leukocyte Antigens
Interleukin
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2015-08-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: HLA levels in the kidney graft biopsy
timeFrame: 12 months
Secondary outcomes:
measure: Renal function
timeFrame: 12 months
measure: Kidney graft survival
timeFrame: 12 months
measure: Surgery complications
timeFrame: 12 months
measure: TNFalpha levels in the kidney graft biopsy
timeFrame: 12 months
measure: IL2 and IL6 levels in the kidney graft biopsy
timeFrame: 12 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Western Medical Center, Mexican Institute of Social Security
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Clotilde Fuentes-Orozco, PhD
role: PRINCIPAL_INVESTIGATOR
References: