Predictors of Rejection in Pediatric Kidney Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 主要终点
- predictors of rejection
研究概览
简要总结
Renal transplantation is the best option among the end-stage renal disease (ESRD) treatment alternatives, It is also relatively less expensive than dialysis. Allograft rejection is a major issue in kidney transplantation. Rejection is classified as acute or chronic, cellular or antibody-mediated.Children with kidney transplants require life-long immunosuppressive therapy to prevent rejection of the allograft
详细描述
The most common medication regimen in the United States includes the combination of corticosteroid (eg, prednisone), a calcineurin inhibitor (or CNI, most commonly tacrolimus), and an antimetabolite such as mycophenolate mofetil (MMF). Cyclosporine and azathioprine are less commonly used for maintenance immunosuppression Tacrolimus level is a main maintenance immunosuppressant in kidney transplantation .In the early days of posttransplant period, hematocrit concentrations are generally low and increase significantly as patient recovers. Because tacrolimus binds strongly to erythrocytes in systemic circulation, the effect of hematocrit on distribution of tacrolimus is important for the methods used to measure tacrolimus concentrations ,hematocrit correction could be a step towards improvement of tacrolimus dose individualization Thearputic drug monitoring of MPA has been proposed to optimize drug dosage avoiding potential hematologic and digestive side effects .MPA monitoring is generally based on the determination of the plasma MPA trough concentration (C0) .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Paediatric living donor kidney transplant recipients (aged 1-18 years)
- •patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids
- •recipients with biopsy proven acute rejection in the studied group.
排除标准
- •patients on cyclosporine
- •patients with active infection and dehydration
- •Patients who received multiorgan transplantation Non cooperative patient will be excluded
研究组 & 干预措施
study group 1
(rejector group )include Paediatric living donor kidney transplant recipients (aged 4-18 years) at least 35 child recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the study group 1 measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test
干预措施: Tacrolimus capsule , mycophenolic acid (Drug)
study group 2
the second group (non rejector group ) include Paediatric living donor kidney transplant recipients (aged 4-18 years) recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the studied group at least 35 child measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test in the study group 2
干预措施: Tacrolimus capsule , mycophenolic acid (Drug)
结局指标
主要结局
predictors of rejection
时间窗: 2 year
detect the potentially predictors of rejection in pediatric kidney transplant recipient
次要结局
- measure corrected tacrolimus level and mycophenolic acid(2 year)
研究者
Aya Khalifa
Principle investigator
Assiut University
