Pediatric Induction Therapy in Kidney Transplantation

Completed

• Conditions: Kidney Transplant Rejection; Pediatric Kidney Disease
• Interventions: Drug: Basiliximab Injection; Drug: rabbit ATG

• Registration Number: NCT06087003
• Lead Sponsor: Gang Chen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-03
• Primary Completion: 2022-07-27
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-15
• Last Update Submitted: 2023-10-15
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 958

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Basilliximab induction group	Basiliximab Injection	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.
rATG induction group	rabbit ATG	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.

Primary Outcome Measures

Name	Time	Method
Acute rejection (AR)	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 Outcome Measures

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

Trial Locations

Locations (5)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

The First Affiliated Hospital of Sun Yat-sen University.; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, China

Changhai Hospital affiliated to Naval Military Medical University; 🇨🇳 Shanghai, China