Pediatric Induction Therapy in Kidney Transplantation (PINK)

Gang Chen

Status: Completed

Conditions: Pediatric Kidney Disease; Kidney Transplant Rejection

Treatments: Drug: Basiliximab Injection; Drug: rabbit ATG

Study type: Observational

Funder types: Other

Identifiers

NCT06087003

PINK study

Details and patient eligibility

About

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.

Enrollment: 958 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

958 participants in 2 patient groups

Basilliximab induction group

Description:

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.

Treatment:

Drug: Basiliximab Injection

rATG induction group

Description:

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.

Treatment:

Drug: rabbit ATG