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WithdrawnNCT01711996Updated May 6, 2021

The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients

An observational study in Ureteropelvic Junction Obstruction, sponsored by Yonsei University. Withdrawn at 1 site in Korea, Republic of. Open to participants aged Up to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-06.

Sponsored by Yonsei University · Observational

Why this study was withdrawn
Difficulty in purchasing reagents and receiving consent from the subject
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
Up to 3 Years
Sex
All
01

Study summary

Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction (UPJO) patients. We are trying to analyze whether it is related with the grade of renal injury in UPJO patients.

02

Conditions studied

  • Ureteropelvic Junction Obstruction

Keywords

  • hydronephrosis
  • biopsy
  • biomarker
03

In context

Multicystic renal dysplasia, bilateral

26 studies on the registry are indexed under Multicystic renal dysplasia, bilateral; 9 are open to participants now.

Browse Multicystic renal dysplasia, bilateral studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.

Browse Yonsei University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 3 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Group 1: 20 patients with UPJO undergo pyeloplasty Group 2: 20 patients with hydronephrosis who does not meet the indication of pyeloplasty Group 3: 20 normal control

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

\<Group 1>

  1. 0-3 year old patients with SFU grade 2 or more hydronephrosis without ureteral dilatation
  2. needs pyeloplasty due to differential renal function (DRF)\<40%, decreased DRF by more than 5%, development of urinary tract infection, development of urinary stone, and development of pain related with UPJO \<Group 2>
  1. 0-3 year old patients with SFU grade 3 or 4 hydronephrosis without ureteral dilatation 2. doesn't meet the above criteria for the indication of pyeloplasty \<Group 3>
  1. 0-3 year old children without any abnormality of urinary tract

Exclusion criteria

Exclusion Criteria:

\<Group 1>

  1. patients with contralateral disease affecting DRF
  2. history of previous urinary tract surgery
  3. follow up loss before diuretic renogram performed at 6-12 months from operation \<Group 2, 3>
  1. patients with contralateral disease affecting DRF 2. history of previous urinary tract surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • UPJO

    0-3 year old hydronephrosis patients without ureter dilatation who undergo pyeloplasty

  • Hydronephrosis

    0-3 year old hydronephrosis patients without ureter dilatation who does not meet the indication of pyeloplasty

  • Normal

    0-3 year old children without hydronephrosis

06

What researchers measure

Primary outcomes

  1. The level of urinary NGAL and the degree of renal injury

    Analysis of correlation between the level of urinary NGAL and the degree of renal injury

    Time frame: 6 month after operation

07

Study locations

1 site
  • Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
    Seoul, 120-752, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2012, a primary completion of Aug 2012 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2012
First posted
Oct 23, 2012
Start
Aug 2012
Primary completionActual
Aug 2012
CompletionEst.
Aug 2013
Last update
May 6, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01711996
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Oct 23, 2012
Start date
Aug 2012
Primary completion
Aug 2012
Completion
Aug 2013 (estimated)
Last update
May 6, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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