Prognosis Study of Renal Transplantation in Children

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT03708094

Collaborator

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

184

Enrollment

Location

37.9

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure	Diagnostic Test: molecular diagnosis

Study Design

Study Type:

Observational

Actual Enrollment :

184 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Renal graft survival rate [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 Outcome Measures

Incidence of acute rejection [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.
Recurrence rate of primary disease [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's hospital of Fudan university	Shanghai	Shanghai	China	200000

Sponsors and Collaborators

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

Investigators

Principal Investigator: Hong Xu, MD.PhD, Children's Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hong Xu，MD.PhD, Professor, Children's Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT03708094

Other Study ID Numbers:

TxGene 1.0

First Posted:

Oct 17, 2018

Last Update Posted:

Jan 5, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hong Xu，MD.PhD, Professor, Children's Hospital of Fudan University

prognosis

pathogenic gene

decision tree study

Additional relevant MeSH terms:

Renal Insufficiency

Study Results

No Results Posted as of Jan 5, 2022