Atorvastatin in the Recipient's Kidney Graft From a Living Donor
- Registration Number
- NCT02522117
- Lead Sponsor
- Instituto Mexicano del Seguro Social
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Accepted as kidney donor
- Voluntary participation
- Informed consent accepted
- 85% fulfillment of atorvastatin treatment
- Entitlement to the Mexican Institute of Social Security
Donors
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 24 patients received oral placebo 40 mg once a day, for 4 weeks. Atorvastatin Atorvastatin 24 patients received oral atorvastatin 40 mg once a day, for 4 weeks.
- Primary Outcome Measures
Name Time Method HLA levels in the kidney graft biopsy 12 months HLA levels were measure by immunohistochemistry, observing alteration between groups.
- Secondary Outcome Measures
Name Time Method Renal function 12 months 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.
Kidney graft survival 12 months 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.
Surgery complications 12 months During surgical procedure and following, any kind of complication was registered.
TNFalpha levels in the kidney graft biopsy 12 months TNFalpha levels were measure by immunohistochemistry, observing alteration between groups.
IL2 and IL6 levels in the kidney graft biopsy 12 months IL2 and IL6 levels were measure by immunohistochemistry, observing alteration between groups.
Trial Locations
- Locations (1)
Western Medical Center, Mexican Institute of Social Security
🇲🇽Guadalajara, Jalisco, Mexico