Atorvastatin in the Recipient's Kidney Graft From a Living Donor (ATORV15)

Instituto Mexicano del Seguro Social

Status and phase: Completed; Phase 3

Conditions: Renal Insufficiency

Treatments: Drug: Placebo; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02522117

R-2013-1301-100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Description:

24 patients received oral atorvastatin 40 mg once a day, for 4 weeks.

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

24 patients received oral placebo 40 mg once a day, for 4 weeks.

Treatment:

Drug: Placebo