Kidney FailureNCT03708094
Prognosis Study of Renal Transplantation in Children
An observational study of Kidney Failure, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Kidney Failure
- What is being tested?
- molecular diagnosis
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of 300 continuous renal transplant cases from multiple centers included in this study
Who may be able to join
- Donors and recipients who accepted kidney transplantation at centers included in this study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Study for Predicting the Prognosis of Renal Transplantation by the Clear Pathogenic Gene of End-stage Renal Disease in Children
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
- Being tested
- molecular diagnosis
- Keywords
- prognosis, pathogenic gene, decision tree study
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular diagnosisDiagnostic test
whole exome sequencing and data analysis to elucidating molecular diagnosis
| Study group | Role | What they receive |
|---|---|---|
| molecular diagnosis confirmed | Whole exome sequencing is applied to children and the molecular diagnosis was identified before renal transplantation. Receives: Diagnostic Test: molecular diagnosis | |
| molecular diagnosis unconfirmed | Whole exome sequencing is applied to children and the molecular diagnosis was not identified before renal transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years after renal transplantation
Secondary outcomes (2)
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.
Measured: 3 years after renal transplantation
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.
Measured: 3 years after renal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Nov 2018
- Primary completion30 Dec 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Central South University, Tongji Hospital
- Responsible party
- Principal investigator, Hong Xu，MD.PhD, Children's Hospital of Fudan University
- Investigators
- Hong Xu, MD.PhD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708094
- Sponsor's protocol ID
- TxGene 1.0
- Status last verified
- Jan 2022
- First submitted
- 10 Oct 2018
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Predicting the Prognosis of Renal Transplantation by the Clear Pathogenic Gene of End-stage Renal Disease in Children
- ClinicalTrials.gov ID
- NCT03708094
- Acronym / sponsor ID
- TxGene 1.0
- Conditions
- Kidney Failure
- Keywords
- prognosis, pathogenic gene, decision tree study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Central South University, Tongji Hospital
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| molecular diagnosis confirmed | – | Diagnostic Test: molecular diagnosisWhole exome sequencing is applied to children and the molecular diagnosis was identified before renal transplantation. |
| molecular diagnosis unconfirmed | – | –Whole exome sequencing is applied to children and the molecular diagnosis was not identified before renal transplantation. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of 300 continuous renal transplant cases from multiple centers included in this study
Key inclusion criteria (1 listed)
- Donors and recipients who accepted kidney transplantation at centers included in this study
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular diagnosiswhole exome sequencing and data analysis to elucidating molecular diagnosis | Diagnostic test | molecular diagnosis confirmed |
Primary outcome
Renal graft survival rate
Time frame: 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.
2 secondary outcomes
Incidence of acute rejection
Time frame: 3 years after renal transplantation
Recurrence rate of primary disease
Time frame: 3 years after renal transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Xu, MD.PhD principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal graft survival rate (time frame: 3 years after renal transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.