Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cytokines Evaluation
研究概览
简要总结
Currently, acute kidney injury is diagnosed by increased serum creatinine. However, creatinine is not a reliable marker for acute changes in renal function.
The biology of the renal graft is influenced by chemokines from reperfusion (just after the kidney transplant) and throughout its course, when acute and chronic inflammatory changes occurs. Moreover, the evaluation of changes in urinary cytokines reflects kidney interstitial patterns, and can predict renal function, acute rejection episodes and their response to treatment.
Today there are several studies comparing the relative immunosuppression of renal function, but few noticed its relationship with cytokines and chemokines. Thus, we proposed studying the inflammatory consequences of early calcineurin inhibitors (ICN) withdrawing in transplant patients by urine analysis. Kidney biopsy was done before ICN withdrawn and replaced by everolimus (3 months after transplant), and 1 year after transplant.
详细描述
- Research objectives
OBJECTIVES
Main Objectives:
• Evaluate the urinary chemokines in kidney transplant patients taking prednisone, tacrolimus and mycophenolate sodium compared to those in use prednisone, mycophenolate sodium and everolimus as maintenance immunosuppression.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old and under 65 years old
- •Recipients of first kidney transplant
- •Donor younger than 65 years old
- •PRA (panel reactive antigen) ≤ 30% in class I or class II
- •No acute rejection episodes
- •Proteinuria <1000 mg / day
排除标准
- •multiple organ transplant recipient
- •Chronic liver failure
- •Asymptomatic bacteriuria or urinary infection at randomization time
- •Creatinine ≥ 2 mg / dL at randomization time (90 days after transplant)
- •Presence of uncontrolled hypercholesterolemia (≥ 350 mg / dL, ≥ 9.1 mmol / L) or hypertriglyceridemia (≥ 500 mg / dL, ≥ 5.6 mmol / L) at randomization time (90 days after transplant)
研究组 & 干预措施
everolimus
Kidney transplant patients with living or deceased donors using tacrolimus, mycophenolate sodium and prednisone, and converted for everolimus, mycophenolate sodium, and prednisone 90 days after renal transplantation.
干预措施: Everolimus (Drug)
结局指标
主要结局
Cytokines Evaluation
时间窗: Urine and biopsy data are collected 90 days and 365 days after transplant.
Cd106(VCAM-1) , IP-10/CXCL10, MIG/CXCL9, MCP-1/CCL2, IL-1, RANTES, IL-8, IL12p70, TNF, IL-10, IL-6, IL-1, VEGF, FGF, CD54(ICAM-1) were analysed in urine 90 days after transplant (before randomization), and 365 days after transplant. Material were conserved at -80 Celsius, and analysed by ELISA at same time. Data was shown in MFI units
次要结局
- Evaluation of Renal Function(90 days after transplant and 365 days after transplant)
研究者
Andre Barreto Pereira
MD, Msc, PhD
Santa Casa de Misericórdia de Belo Horizonte