Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- C-Reactive Protein evolution in donors
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accepted as kidney donor
- •Voluntary participation
- •Informed consent accepted
- •85% fulfillment of atorvastatin treatment
排除标准
- •Hypersensibility to Atorvastatin
研究组 & 干预措施
Atorvastatin
22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks
干预措施: Atorvastatin (Drug)
Placebo
22 patients received oral placebo 40 mg 1 time for day for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
C-Reactive Protein evolution in donors
时间窗: 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
时间窗: 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.
次要结局
- Kidney function evolution after transplant(24 hours, 3 months and 12 months)
- Interleukin and tumor necrosis factor alpha.(Basal)
- Complications(24 hours, 3 months and 12 months)
研究者
CLOTILDE FUENTES OROZCO
PhD
Instituto Mexicano del Seguro Social