Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney

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

NCT02355704

2011-1301-78

Details and patient eligibility

About

Renal Insufficiency is a priority disease in health system, which may require renal replacement therapy based on renal transplantation, which is considered as therapy of choice. During the procedure of renal transplantation, the graft could be damaged by ischemia-reperfusion which generates complications in its function.

Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.

Full description

Objective: Evaluate anti-inflammatory effect of atorvastatin on renal graft in living donor transplantation.

Material and methods: Controlled, double-blind clinical trial with posterior following for 12 months. Composed by 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. Patients were randomized in two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. Previous surgical procedure, in a blood sample, C-Reactive Protein (C-RP) and laboratory control were measured. During surgical procedure, a biopsy was obtained to measure IL-6 and tumoral necrosis factor alpha by immunohistochemistry. 24 hours after surgical procedure, 3 and 12 months of following, kidney function, complications and graft survival were registered. During surgical procedure, 3 months and 12 months of following, biopsies were obtain to performed histopathological analysis of scale of Banff

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Accepted as kidney donor
• Voluntary participation
• Informed consent accepted
• 85% fulfillment of atorvastatin treatment

Exclusion criteria

• Hypersensibility to Atorvastatin
• Smoking

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:

22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

22 patients received oral placebo 40 mg 1 time for day for 4 weeks

Treatment:

Drug: Placebo