Prognosis Study of Renal Transplantation in Children

Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708094
• Other study ID #: TxGene 1.0
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2022
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Diagnostic Test:
• molecular diagnosis
whole exome sequencing and data analysis to elucidating molecular diagnosis

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai

Sponsors (6)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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