Prognosis Study of Renal Transplantation in Children

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

Study Overview

• Status: Completed
• Conditions: Kidney Failure
• Intervention / Treatment: Diagnostic test: molecular diagnosis

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 300 continuous renal transplant cases from multiple centers included in this study

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
molecular diagnosis confirmed; Whole exome sequencing is applied to children and the molecular diagnosis was identified before renal transplantation.	Diagnostic test: molecular diagnosis; whole exome sequencing and data analysis to elucidating molecular diagnosis
molecular diagnosis unconfirmed; Whole exome sequencing is applied to children and the molecular diagnosis was not identified before renal transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal graft survival rate	The number of survival renal transplant graft in the 3 year observation period accounted for the percentage of the total cases studied.	3 years after renal transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute rejection	The number of acute rejection after transplantation during the 3 year observation period accounted for the percentage of the total cases studied.	3 years after renal transplantation
Recurrence rate of primary disease	The number of patient with primary disease recurrence during the 3 year observation period accounted for the percentage of the total cases studied.	3 years after renal transplantation

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Boston Children's Hospital; First Affiliated Hospital, Sun Yat-Sen University; Tongji Hospital; The First Affiliated Hospital of Zhengzhou University; Central South University
• Investigators: Principal Investigator: Hong Xu, MD.PhD, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: prognosis; pathogenic gene; decision tree study
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: TxGene 1.0

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: No
• Studies a U.S. FDA-regulated device product: No