Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00568724
First received: December 5, 2007
Last updated: September 13, 2012
Last verified: September 2012
  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
Ureteral Obstruction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Urine and frozen pelvic tissue


Enrollment: 45
Study Start Date: November 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Children referred to surgical treatment of congenital hydronephrosis
2
15 age- and sex-matched controls
Children with healthy pelvic tissue
Children referred to nephrectomy due to nephrotic syndrome
Adults with healthy pelvic tissue
Adults referred to nephrectomy due to another cause than hydronephrosis

  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
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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

Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00568724     History of Changes
Other Study ID Numbers: MGM-01
Study First Received: December 5, 2007
Last Updated: September 13, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Hydronephrosis
Ureteral obstruction

Additional relevant MeSH terms:
Hydronephrosis
Ureteral Obstruction
Kidney Diseases
Ureteral Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014