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Pediatric Induction Therapy in Kidney Transplantation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06087003
Acronym
PINK
Enrollment
958
Registered
2023-10-17
Start date
2013-03-03
Completion date
2023-09-30
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Rejection, Pediatric Kidney Disease

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.

Interventions

As an induction treatment for kidney transplantation

As an induction treatment for kidney transplantation

Sponsors

Zhejiang University
CollaboratorOTHER
First Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
Changhai Hospital
CollaboratorOTHER
Gang Chen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026