Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
- Registration Number
- NCT02355704
- Lead Sponsor
- Instituto Mexicano del Seguro Social
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Accepted as kidney donor
- Voluntary participation
- Informed consent accepted
- 85% fulfillment of atorvastatin treatment
- Hypersensibility to Atorvastatin
- Smoking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 22 patients received oral placebo 40 mg 1 time for day for 4 weeks Atorvastatin Atorvastatin 22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks
- Primary Outcome Measures
Name Time Method C-Reactive Protein evolution in donors Basal and 4 weeks later C-Reactive Protein was measured when patients (donors) were accepted in the study and 4 weeks later. The last blood sample was taken the day of surgical procedure.
Kidney graft rejection using scale of BANFF Basal, 3 months and 12 months During surgical procedure and before organ transplantation, basal biopsy was obtain. In the following at 3 and 12 months after kidney transplantation, were performed the other two biopsy. Alterations between groups were registered.
- Secondary Outcome Measures
Name Time Method Kidney function evolution after transplant 24 hours, 3 months and 12 months In blood samples, after kidney transplantation, creatinine and urea were measured. Differences in evolution and alteration between the 2 groups were registered
Interleukin and tumor necrosis factor alpha. Basal During surgical procedure and before organ transplantation, the biopsy was obtain to measure interleukin 6 and tumor necrosis factor alpha, observing alteration between groups.
Complications 24 hours, 3 months and 12 months During surgical procedure, any kind of complication was registered, the same right after surgery and in the following.
Trial Locations
- Locations (1)
Western Medical Center, Mexican Institute of Social Security
🇲🇽Guadalajara, Jalisco, Mexico