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OpenTrials
Completed

NCT Number: NCT06087003

Pediatric Induction Therapy in Kidney Transplantation

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.

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Key information

Conditions

Kidney Transplant Rejection Pediatric Kidney Disease

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basiliximab Injection

Drug

As an induction treatment for kidney transplantation

Other names: Simulect

Rabbit ATG

Drug

As an induction treatment for kidney transplantation

Other names: Thymoglobuline

Primary outcomes

  1. 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

  1. Cytomegalovirus (CMV) viremia

    Time frame: From baseline, kidney transplantation to data collection completion (June 30, 2023)

    The serum CMV is greater than 500 copies/ml

  2. Pneumonia

    Time frame: From baseline, kidney transplantation to data collection completion (June 30, 2023)

    Any pneumonia that showed the presence of lesion and required hospitalization

  3. Renal graft survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Gang Chen

Other

Collaborators

  • Changhai Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
  • The First Affiliated Hospital of Zhengzhou University
  • Zhejiang University

Registry information

Official study title

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

Acronym: PINK

Important dates

Study start
2013
Primary completion
2022
Study completion
2023
First posted
Oct 17, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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