Pediatric Induction Therapy in Kidney Transplantation (PINK)

October 15, 2023 updated by: Gang Chen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

958

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China
        • The First Affiliated Hospital of Zhejiang University
      • Shanghai, China
        • Changhai Hospital affiliated to Naval Military Medical University
      • Wuhan, China, 430030
        • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Sun Yat-sen University.
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The cohort will be selected from five centers with the highest number of pediatric kidney transplant cases in China, including Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Changhai Hospital Affiliated to Naval Medical University, the First Affiliated Hospital of Zhengzhou University, the First Affiliated Hospital of Zhejiang University and the First Affiliated Hospital of Sun Yat-sen University.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Basiliximab Injection
As an induction treatment for kidney transplantation
Other Names:
  • Simulect
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.
Drug: rabbit ATG
As an induction treatment for kidney transplantation
Other Names:
  • Thymoglobuline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline, kidney transplantation to data collection completion (June 30, 2023)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline, kidney transplantation to data collection completion (June 30, 2023)
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
From baseline, kidney transplantation to data collection completion (June 30, 2023)
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
From baseline, kidney transplantation to data collection completion (June 30, 2023)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gang Chen

Collaborators

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

Investigators

  • Principal Investigator: Gang Chen, PhD, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2013

Primary Completion (Actual)

July 27, 2022

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 15, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 15, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINK study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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