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Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568724
First Posted: December 6, 2007
Last Update Posted: September 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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

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

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.
  Contacts and Locations
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
  More Information

Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00568724     History of Changes
Other Study ID Numbers: MGM-01
First Submitted: December 5, 2007
First Posted: December 6, 2007
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