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Completed

NCT Number: NCT03708094

Prognosis Study of Renal Transplantation in Children

Kidney transplantation is the worldwide recognized best renal replacement treatment for children with end-stage renal disease. Successful kidney transplantation can not only alleviate uremia symptoms, improve survival and quality of life, but also achieve optimal growth and cognitive development in children. Clarifying the cause of end-stage renal disease before transplantation is of vital importance to the comprehensive assessment and follow-up of the extra renal organs, reducing the risk of recurrence of the primary disease, the choice of the timing and the mode of transplantation, the scheme of immunosuppressive agents, as well as providing accurate genetic counseling for families. Timely molecular diagnosis and correct data analysis play a positive role in promoting the etiological diagnosis of uremic children before renal transplantation. We hypothesized that identifying the molecular diagnosis can improve prognosis of kidney transplantation. 300 cases of end-stage renal disease children were included and whole exome sequencing are performed to identify the molecular diagnosis. The cohort was divided into 2 groups according to whether the molecular diagnosis was clear. Clinical information before and after renal transplantation of each group are collected, and the decision tree analysis model and logistic regression model are used to study the effect of clear molecular diagnosis on the 3 year survival rate of renal transplantation.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Donors and recipients who accepted kidney transplantation at centers included in this study

Exclusion criteria

  • Older than 18 years old.
  • There are severe systemic diseases and/or local and/or spiritual system diseases.
  • There are systemic acute or chronic infections, infectious diseases.
  • The donated organ dysfunction, or other causes that are damage to donors and recipients.

Treatment and study plan

molecular diagnosis

Diagnostic Test

whole exome sequencing and data analysis to elucidating molecular diagnosis

Primary outcomes

  1. Renal graft survival rate

    Time frame: 3 years after renal transplantation

    The number of survival renal transplant graft in the 3 year observation period accounted for the percentage of the total cases studied.

Secondary outcomes

  1. Incidence of acute rejection

    Time frame: 3 years after renal transplantation

    The number of acute rejection after transplantation during the 3 year observation period accounted for the percentage of the total cases studied.

  2. Recurrence rate of primary disease

    Time frame: 3 years after renal transplantation

    The number of patient with primary disease recurrence during the 3 year observation period accounted for the percentage of the total cases studied.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Boston Children's Hospital
  • Central South University
  • First Affiliated Hospital, Sun Yat-Sen University
  • The First Affiliated Hospital of Zhengzhou University
  • Tongji Hospital

Registry information

Official study title

A Study for Predicting the Prognosis of Renal Transplantation by the Clear Pathogenic Gene of End-stage Renal Disease in Children

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 17, 2018
Registry last updated
Jan 5, 2022

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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