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Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

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ClinicalTrials.gov Identifier: NCT00568724
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : September 14, 2012
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease
Ureteral Obstruction

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis
Study Start Date : November 2007
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. Urinary cytokines [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Urine and frozen pelvic tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00568724     History of Changes
Other Study ID Numbers: MGM-01
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: September 2012

Keywords provided by University of Aarhus:
Hydronephrosis
Ureteral obstruction

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