Prognosis Study of Renal Transplantation in Children

NCT03708094 | Completed

• 1 other identifier: TxGene 1.0
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure

Keywords

prognosis; pathogenic gene; decision tree study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of acute rejection

  3 years after renal transplantation

• Recurrence rate of primary disease

  3 years after renal transplantation

Study Arms (2)

molecular diagnosis confirmed

Whole exome sequencing is applied to children and the molecular diagnosis was identified before renal transplantation.

Diagnostic Test: molecular diagnosis

molecular diagnosis unconfirmed

Whole exome sequencing is applied to children and the molecular diagnosis was not identified before renal transplantation.

Interventions

molecular diagnosis DIAGNOSTIC_TEST

whole exome sequencing and data analysis to elucidating molecular diagnosis

molecular diagnosis confirmed

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hong Xu, MD.PhD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 17, 2018
• Study Start: November 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)