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NCT00568724 Clinical Trial

Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

Ureteral Obstruction Clinical Trial

Official title:
Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00568724
Other study ID # MGM-01
Secondary ID
Status Completed
Phase N/A
First received December 5, 2007
Last updated September 13, 2012
Start date November 2007
Est. completion date January 2012

Study information
Verified date September 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 15 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Institute of Clinical Medicine, University of Aarhus Aarhus

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Madsen MG, Nørregaard R, Palmfeldt J, Olsen LH, Frøkiær J, Jørgensen TM. Urinary NGAL, cystatin C, ß2-microglobulin, and osteopontin significance in hydronephrotic children. Pediatr Nephrol. 2012 Nov;27(11):2099-106. doi: 10.1007/s00467-012-2217-6. Epub 2012 Jun 19. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Urinary cytokines 1 year No
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