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Kidney DiseasesNCT06018831

Urine and Ultrasound Screening for Kidney Disease in Children

A study testing Urine and Ultrasound Screening in people with Kidney Diseases and Diagnostic Techniques, run by Children's Hospital of Fudan University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to early detect kidney disease in the natural population cohort of children by urine and ultrasound screening, to assist in the precise prevention and treatment of children's kidney disease, and to establish a risk prediction system for children's kidney disease. Read more about this study

Who is it for?
Ages Up to 6 yearsHealthy volunteers can take part
Conditions the study is for
Kidney Diseases, Diagnostic Techniques, Ultrasound
What is being tested?
Urine and Ultrasound Screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13,000 participants
Where
2 sitesChina
Study dates
12 Apr 2022to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • All consecutive live newborn infants(regardless of physical condition)
  • Complete at least 3 years of follow-up

Who cannot join

  • Declining the screening
  • Missing

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yihui Zhai contact

+8613916488230

marinezyh@163.com

Hong Xu, PhD.MD. contact

+8602164932829

hxu@shmu.edu.cn

China2 sites, 2 recruiting

  • Qidong City Maternal and Child Health Hospital

    Nantong, Jiangsu

    JuanJuan Wu, +8613862875600

    Recruiting

  • Kunshan City Maternal and Child Health Hospita

    Suzhou, Jiangsu

    SuXiang Xu, +8613912668435

    Recruiting

Other trials in China

About this study

The aim of this study is to early detect kidney disease in the natural population cohort of children by urine and ultrasound screening, to assist in the precise prevention and treatment of children's kidney disease, and to establish a risk prediction system for children's kidney disease. About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Through the project, child who is found with abnormal urine or ultrasound result will be referred to Children's Hospital of Fudan University to get further examination and treatment.

Read the detailed description

Chronic kidney disease (CKD) often has an insidious onset. Early detection of CKD and more aggressive treatment and monitoring of high-risk CKD patients at risk of progression are the consensus of current medical practice. However, there is currently no CKD risk prediction system for the Chinese population, especially children. The main goal of this project is to establish a risk prediction system for children's kidney disease, and to assist in the precise prevention and treatment of children's kidney disease. The project is based on the "urine and ultrasound screening" strategy that has been carried out for more than ten years in Shanghai, using a non-invasive and effective screening method in the natural population cohort of children, in order to detect kidney disease in the early stage.

Being tested
Urine and Ultrasound Screening
Medical subject headings
Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urine and Ultrasound ScreeningOther

    When an infant was born, he/she will receive the first urine and ultrasound screening in 3 months in Kunshan/Qidong City Maternal and Child Health Hospital.In Kunqi Cohort, 9,000 will complete 3 years follow-up(urine screening once every year, another ultrasound screening in 24-30 months). Urine sample (50ml) will be stored only once within one year. Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for future study.1,000 children will complete 6 year follow-up(receive urine and ultrasound screening once every year). Urine sample (50ml) will be stored once a year. Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for future study. The 14 urine test items include: leukocytes, urobilinogen, microalbumin, protein, bilirubin, glucose, ascorbic acid, specific gravity, ketone bodies, nitrite, creatinine, pH, occult blood, and urinary calcium. Ultrasound test will screen for kidneys, ureters and the bladder.

Study groups in NCT06018831
Study groupRoleWhat they receive
Urine and Ultrasound ScreeningExperimentalAbout 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Children will receive urine and ultrasound screening in 0-3 months ,and complete 3 to 6 years of follow-up( at least one type screening every year)
Receives: Other: Urine and Ultrasound Screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence, incidence, and incidence of renal disease progression in children with CKD

    The number of CKD patients diagnosed according to the routine diagnosis and treatment of the department of nephrology in Children's Hospital of Fudan University in the 3-6 year observation period accounted for the percentage of the total cases studied.

    Measured: From baseline to the third or sixth year of the study

Secondary outcomes (3)

  1. Urine metabolomic and proteomic profiles in KunQi Cohort

    9,000 children's urine samples (50ml) will be stored as biospecimen retention at -80°C only once within one year, another 1,000 children's urine samples (50ml) will be stored also as biospecimen retention at -80°C once a year.

    Biospecimen retention will be used to characterize the urinary and metabolome and proteome in children also expect to identify urine biomarkers for the early diagnosis of CKD.

    Measured: From baseline to the third or sixth year of the study

  2. Blood metabolomic and DNA profiles in KunQi Cohort

    Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for metabolomic study and DNA extraction, aiming to identify blood metabolomic biomarkers and DNA mutations for the early diagnosis of CKD.

    Measured: From baseline to the third or sixth year of the study

  3. Potential risk factors asked within questionnaire for the onset, development and prognosis of CKD in children

    Every child's patient will be asked to complete 3-6 year follow-up questionnaire once a year(include Children Kidney Health Survey for first-year baseline questionnaire and Chilren Kidney Health Survey as every year's follow-up questionnaire) when undergoing routine child health checkups, which includes health conditions and kidney disease related events including family history, mother's height and weight before and after pregnancy (used to calculate BMI), parents' smoking and drinking history, whether the mother takes antihypertensive drugs and the type, parents' occupational exposure history, drinking water quality, take-out frequency, mother's first child bearing age and the age of this child bearing, newborn hospitalization history. These potential risk factors analyzed by statistical methods are aimed to predict the onset, development and prognosis of CKD in children.

    Measured: From baseline to the third or sixth year of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2023
  2. Study start12 Apr 2022
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06018831
Sponsor's protocol ID
2021YFC2500202
Status last verified
Mar 2026
First submitted
3 Feb 2023
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gong Y, Zhang Y, Shen Q, Xiao L, Zhai Y, Bi Y, Shen J, Chen H, Li Y, Xu H. Early detection of congenital anomalies of the kidney and urinary tract: cross-sectional results of a community-based screening and referral study in China. BMJ Open. 2018 May 30;8(5):e020634. doi: 10.1136/bmjopen-2017-020634.

    PubMed 29848771

  • Gong Y, Xu H, Li Y, Zhou Y, Zhang M, Shen Q, Huang J, Xu H, Bi Y, Chen H, Zhang Y, Wang J. Exploration of postnatal integrated management for prenatal renal and urinary tract anomalies in China. J Matern Fetal Neonatal Med. 2021 Feb;34(3):360-365. doi: 10.1080/14767058.2019.1608176. Epub 2019 Apr 29.

    PubMed 30983458

  • Zhai YH, Xu H, Zhu GH, Wei MJ, Hua BC, Shen Q, Rao J, Ge J. Efficacy of urine screening at school: experience in Shanghai, China. Pediatr Nephrol. 2007 Dec;22(12):2073-9. doi: 10.1007/s00467-007-0629-5. Epub 2007 Oct 18.

    PubMed 17943322

  • Shen Y, Liu T, Liu J, Han X, Wu J, Xie L, Chen X, Xu B, Sun Y, Xu S, Zhang Q, Xie N, Zhang L, Ji J, Mo W, Liu Y, Shi X, Shen J, Qiu W, Huang J, Shen Q, Zhai Y, Xu H; KQBC group. Kun-Qi birth cohort (KQBC) study for the incidence, aetiology and risk factors of chronic kidney disease in Chinese children: a cohort profile. BMJ Open. 2025 Aug 16;15(8):e102702. doi: 10.1136/bmjopen-2025-102702.

    PubMed 40819875

Questions about this trial

What is this clinical trial studying?

A study testing Urine and Ultrasound Screening in people with Kidney Diseases and Diagnostic Techniques, run by Children's Hospital of Fudan University at 2 sites 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yihui Zhai (+8613916488230, marinezyh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence, incidence, and incidence of renal disease progression in children with CKD (time frame: From baseline to the third or sixth year of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06018831, which also lists 4 linked publications.

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 27 Mar 2026.

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