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Predictors of Rejection in Pediatric Kidney Transplantation

Predictors of Rejection in Pediatric Kidney Transplantation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04292418
Enrollment
70
Registered
2020-03-03
Start date
2020-05-01
Completion date
2021-10-01
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rejection Acute Renal

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) .

Interventions

DRUGTacrolimus capsule , mycophenolic acid

measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test for study group 1 and study group 2

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
predictors of rejection2 yeardetect the potentially predictors of rejection in pediatric kidney transplant recipient

Secondary

MeasureTime frameDescription
measure corrected tacrolimus level and mycophenolic acid2 yeardetect 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

Contacts

Primary ContactAya Khalifa, master degree
dr.ayaahmedkhlifa@gmail.com00201016228446
Backup ContactDoaa Salah, MD
doaamsalah2010@yahoo.com002001205551924

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026