Effectiveness of Atorvastatin on IL2, IL6, TNFalpha and HLA Levels in the Recipient's Kidney Graft From a Living Donor
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
- HLA levels in the kidney graft biopsy
研究概览
简要总结
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.
详细描述
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.
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
- •Entitlement to the Mexican Institute of Social Security
排除标准
- •Hypersensibility to Atorvastatin
- •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
研究组 & 干预措施
Atorvastatin
24 patients received oral atorvastatin 40 mg once a day, for 4 weeks.
干预措施: Atorvastatin (Drug)
Placebo
24 patients received oral placebo 40 mg once a day, for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
HLA levels in the kidney graft biopsy
时间窗: 12 months
HLA levels were measure by immunohistochemistry, observing alteration between groups.
次要结局
- Renal function(12 months)
- Kidney graft survival(12 months)
- Surgery complications(12 months)
- TNFalpha levels in the kidney graft biopsy(12 months)
- IL2 and IL6 levels in the kidney graft biopsy(12 months)
研究者
CLOTILDE FUENTES OROZCO
PhD
Instituto Mexicano del Seguro Social