Predictors of Rejection in Pediatric Kidney Transplantation
- Conditions
- Rejection Acute Renal
- Interventions
- Registration Number
- NCT04292418
- Lead Sponsor
- Assiut University
- Brief Summary
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
- Detailed Description
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) .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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.
- patients on cyclosporine
- patients with active infection and dehydration
- Patients who received multiorgan transplantation Non cooperative patient will be excluded
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description study group 1 Tacrolimus capsule , mycophenolic acid (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 study group 2 Tacrolimus capsule , mycophenolic acid 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
- Primary Outcome Measures
Name Time Method predictors of rejection 2 year detect the potentially predictors of rejection in pediatric kidney transplant recipient
- Secondary Outcome Measures
Name Time Method measure corrected tacrolimus level and mycophenolic acid 2 year detect the role of corrected tacrolimus level in dose adjustment for better control of immunosuppressive therapy detect the role of neutrophil to lymphocytic ratio in prediction of kidney rejection Role of mycophenolic acid monitoring in prevention of rejection