Prognosis Study of Renal Transplantation in Children

Completed

• Conditions: Kidney Failure
• Interventions: Diagnostic Test: molecular diagnosis

• Registration Number: NCT03708094
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2018-11-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Children's hospital of Fudan university; 🇨🇳 Shanghai, Shanghai, China