Clinical trial NCT02355704: Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
Official title: Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Insufficiency
Keywords: Kidney Transplantation
Atorvastatin
C-Reactive Protein
Biopsy
Interleukin
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2015-02-04
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 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Hypersensibility to Atorvastatin
* Smoking

Primary outcomes:
measure: C-Reactive Protein evolution in donors
timeFrame: Basal and 4 weeks later
measure: Kidney graft rejection using scale of BANFF
timeFrame: Basal, 3 months and 12 months
Secondary outcomes:
measure: Kidney function evolution after transplant
timeFrame: 24 hours, 3 months and 12 months
measure: Interleukin and tumor necrosis factor alpha.
timeFrame: Basal
measure: Complications
timeFrame: 24 hours, 3 months and 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: STUDY_DIRECTOR
References: