Pediatric Induction Therapy in Kidney Transplantation

Study Overview
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Brief Summary
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The goal of this observational study is to compare the efficacy of two most commonly used induction therapy for the prevention of acute rejection (AR) after renal transplantation in children. The main question it aims to answer is: Is basiliximab (anti-CD25 monoclonal antibody) induction therapy effective and safe in preventing AR after kidney transplantation in children compared with anti-thymoglobulin polyclonal antibodies induction therapy? The transplant and follow-up data of participants will be retrospectively collected. Researchers will compare the rate of AR to see if basiliximab (anti-CD25 monoclonal antibody) induction therapy is a better option for certain pediatric kidney transplant recipients.

Official Title
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Induction Therapy of Thymoglobulin Versus Basiliximab in the Prevention of Acute Rejection After Pediatric Kidney Transplantation

Conditions
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Kidney Transplant Rejection, Pediatric Kidney Disease

Intervention / Treatment
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* Drug: Basiliximab Injection
* Drug: rabbit ATG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving the kidney graft from a deceased donor Basiliximab or rATG induction therapy was used in perioperative period Exclusion Criteria: Recipients with pre-transplant calculated panel reactive antibodies (cPRA) >10% Recipients of combined liver, pancreas or heart transplantation No induction or other induction therapy was used in perioperative period Recieving the kidney graft from a living donor

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basilliximab induction group<br>Basiliximab was administered intravenously 4 hours before kidney graft reperfusion and at day 4 after kidney transplantation. For pediatric patients weighing > 30kg, the dose of Basiliximab was 20mg, otherwise was 10mg. | Drug: Basiliximab Injection<br>* As an induction treatment for kidney transplantation<br>* Other names: Simulect;|
| rATG induction group<br>Rabbit antithymoglobulin (rATG) was administered intravenously during kidney transplantation (pre-reperfusion) and 1-2 days after transplantation. The dose was about 0.5-1 mg/kg per day. | Drug: rabbit ATG<br>* As an induction treatment for kidney transplantation<br>* Other names: Thymoglobuline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rejection (AR) | The clinical diagnosis of AR is based on a significant increase in serum creatinine and the exclusion of other causes. The diagnosis of biopsy-confirmed AR is based on relevant histological changes. | From baseline, kidney transplantation to data collection completion (June 30, 2023) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytomegalovirus (CMV) viremia | The serum CMV is greater than 500 copies/ml | From baseline, kidney transplantation to data collection completion (June 30, 2023) | 
| Pneumonia | Any pneumonia that showed the presence of lesion and required hospitalization | From baseline, kidney transplantation to data collection completion (June 30, 2023) | 
| Renal graft survival | The estimated glomerular filtration rate (eGFR) of patient is >15 ml/min/1.73m2 | From baseline, kidney transplantation to data collection completion (June 30, 2023) |