Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

NCT ID: NCT00568724

Last Updated: 2012-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to detect new urinary biomarkers that can be used as predictors on renal function in congenital hydronephrosis caused by unilateral ureteral obstruction (UUO) and to elucidate the pathophysiology of UUO.

Detailed Description

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Conditions

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Ureteral Obstruction

Keywords

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Hydronephrosis Ureteral obstruction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Children referred to surgical treatment of congenital hydronephrosis

No interventions assigned to this group

2

15 age- and sex-matched controls

No interventions assigned to this group

Children with healthy pelvic tissue

Children referred to nephrectomy due to nephrotic syndrome

No interventions assigned to this group

Adults with healthy pelvic tissue

Adults referred to nephrectomy due to another cause than hydronephrosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Children referred to surgical treatment of congenital hydronephrosis caused by ureteral obstruction.
* Declining function of the hydronephrotic kidney more than 5 %, and to less than 40 % of the total renal function OR ipsilateral flank pain.

Exclusion Criteria

* Bilateral hydronephrosis
* Previous operation in the urinary system except operation for phimosis and other deformations of the external genital organs.
* Deformations in the lower part of the ureter, bladder and urethra. Urinary stones. Reflux. Urinary tract infections \< 6 months.
* Neurogenic bladder dysfunction.
* GFR \< 40 % standardized to age.
* Non-compliance. Linguistic difficulties.
Minimum Eligible Age

3 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Troels M Jørgensen, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Aarhus University Hospital Skejby

Locations

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Institute of Clinical Medicine, University of Aarhus

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Madsen MG, Norregaard R, Palmfeldt J, Olsen LH, Frokiaer J, Jorgensen TM. Urinary NGAL, cystatin C, beta2-microglobulin, and osteopontin significance in hydronephrotic children. Pediatr Nephrol. 2012 Nov;27(11):2099-2106. doi: 10.1007/s00467-012-2217-6. Epub 2012 Jun 19.

Reference Type BACKGROUND
PMID: 22710694 (View on PubMed)

Other Identifiers

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MGM-01

Identifier Type: -

Identifier Source: org_study_id