Clinical trial NCT03708094: Prognosis Study of Renal Transplantation in Children
Official title: A Study for Predicting the Prognosis of Renal Transplantation by the Clear Pathogenic Gene of End-stage Renal Disease in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure
Keywords: prognosis
pathogenic gene
decision tree study
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Zhengzhou University
name: Central South University
name: Tongji Hospital
First posted: 2018-10-17
Enrollment: 184
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 300 continuous renal transplant cases from multiple centers included in this study

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Renal graft survival rate
timeFrame: 3 years after renal transplantation
Secondary outcomes:
measure: Incidence of acute rejection
timeFrame: 3 years after renal transplantation
measure: Recurrence rate of primary disease
timeFrame: 3 years after renal transplantation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Hong Xu, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: