Clinical trial NCT04292418: Predictors of Rejection in Pediatric Kidney Transplantation
Official title: Predictors of Rejection in Pediatric Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rejection Acute Renal
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paediatric living donor kidney transplant recipients (aged 1-18 years)

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) .

Eligibility criteria: Inclusion Criteria:

1. Paediatric living donor kidney transplant recipients (aged 1-18 years)
2. patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug \[mycophenolate mofetil (MMF) and steroids
3. recipients with biopsy proven acute rejection in the studied group.

Exclusion Criteria:

1. patients on cyclosporine
2. patients with active infection and dehydration
3. Patients who received multiorgan transplantation Non cooperative patient will be excluded

Primary outcomes:
measure: predictors of rejection
timeFrame: 2 year
Secondary outcomes:
measure: measure corrected tacrolimus level and mycophenolic acid
timeFrame: 2 year
Other outcomes:
Locations:
Study officials:
References:
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