Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

This study is enrolling participants by invitation only.

Sponsors and Collaborators:	University of Aarhus Aarhus University Hospital
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00568724

Purpose

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.

Condition
Congenital Hydronephrosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Urinary cytokines [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Urine and frozen pelvis tissue

Estimated Enrollment:	45
Study Start Date:	November 2007
Estimated Study Completion Date:	February 2010

Groups/Cohorts
1 Children referred to surgical treatment of congenital hydronephrosis
2 15 age- and sex-matched controls

Eligibility

Ages Eligible for Study:	3 Months to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Children referred to surgical treatment of congenital hydronephrosis caused by ureteral obstruction.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568724

Locations

Denmark
Institute of Clinical Medicine, University of Aarhus
Aarhus, Denmark, 8200

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Investigators

Principal Investigator:

Troels M Jørgensen, Professor, MD

Department of Urology, Aarhus University Hospital Skejby

More Information

Responsible Party:	Institute of Clinical Medicine, University of Aarhus ( Mia Gebauer Madsen, MD, Ph.d.-student )
Study ID Numbers:	MGM-01
Study First Received:	December 5, 2007
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00568724
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee

Keywords provided by University of Aarhus:

Hydronephrosis
Ureteral obstruction

Study placed in the following topic categories:

Hydronephrosis
Urologic Diseases
Ureteral Obstruction
Kidney Diseases

ClinicalTrials.gov processed this record on January 15, 2009