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临床试验/NCT04292418
NCT04292418Unknown不适用

Predictors of Rejection in Pediatric Kidney Transplantation

Assiut University0 个研究点目标入组 70 人开始时间: 2020年5月1日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Khalifa

Principle investigator

Assiut University

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