NCT06018831

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,000

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Apr 2022Feb 2028

Study Start

First participant enrolled

April 12, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

5.8 years

First QC Date

February 3, 2023

Last Update Submit

March 24, 2026

Conditions

Kidney DiseasesDiagnostic TechniquesUltrasoundUrinalysisChild, Only

Outcome Measures

Primary Outcomes (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.

    From baseline to the third or sixth year of the study

Secondary Outcomes (3)

  • Urine metabolomic and proteomic profiles in KunQi Cohort

    From baseline to the third or sixth year of the study

  • Blood metabolomic and DNA profiles in KunQi Cohort

    From baseline to the third or sixth year of the study

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

    From baseline to the third or sixth year of the study

Study Arms (1)

Urine and Ultrasound Screening

EXPERIMENTAL

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. 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)

Other: Urine and Ultrasound Screening

Interventions

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.

Urine and Ultrasound Screening

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Declining the screening
  • Missing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Qidong City Maternal and Child Health Hospital

Nantong, Jiangsu, China

RECRUITING

Kunshan City Maternal and Child Health Hospita

Suzhou, Jiangsu, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 29848771BACKGROUND

  • 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.

    PMID: 30983458BACKGROUND

  • 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.

    PMID: 17943322BACKGROUND

  • 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.

    PMID: 40819875DERIVED

MeSH Terms

Conditions

Kidney Diseases

Interventions

Urination

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Central Study Contacts

Yihui Zhai

CONTACT

+8613916488230marinezyh@163.com

Hong Xu, PhD.MD.

CONTACT

+8602164932829hxu@shmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

August 31, 2023

Study Start

April 12, 2022

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)