Induction Therapy of Thymoglobulin Versus Basiliximab in the Prevention of Acute Rejection After Pediatric Kidney Transplantation
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gang Chen
- Enrollment
- 958
- Locations
- 5
- Primary Endpoint
- Acute rejection (AR)
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Basilliximab induction group
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.
Intervention: Basiliximab Injection (Drug)
rATG induction group
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.
Intervention: rabbit ATG (Drug)
Outcomes
Primary Outcomes
Acute rejection (AR)
Time Frame: From baseline, kidney transplantation to data collection completion (June 30, 2023)
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.
Secondary Outcomes
- Renal graft survival(From baseline, kidney transplantation to data collection completion (June 30, 2023))
- Cytomegalovirus (CMV) viremia(From baseline, kidney transplantation to data collection completion (June 30, 2023))
- Pneumonia(From baseline, kidney transplantation to data collection completion (June 30, 2023))
Investigators
Gang Chen
Professor
Tongji Hospital