Prognosis Study of Renal Transplantation in Children

NCT ID: NCT03708094

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-12-30

Brief Summary

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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

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Conditions

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Kidney Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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molecular diagnosis confirmed

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

molecular diagnosis

Intervention Type DIAGNOSTIC_TEST

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.

No interventions assigned to this group

Interventions

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molecular diagnosis

whole exome sequencing and data analysis to elucidating molecular diagnosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Hong Xu,MD.PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Xu, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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TxGene 1.0

Identifier Type: -

Identifier Source: org_study_id

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