Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

NCT00568724 | Completed

• 1 other identifier: MGM-01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Obstruction

Keywords

Hydronephrosis; Ureteral obstruction

Outcome Measures

Primary Outcomes (1)

• Urinary cytokines

  1 year

Study Arms (4)

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 Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Institute of Clinical Medicine, University of Aarhus

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Madsen MG, Norregaard R, Palmfeldt J, Olsen LH, Frokiaer J, Jorgensen TM. Urinary NGAL, cystatin C, beta2-microglobulin, and osteopontin significance in hydronephrotic children. Pediatr Nephrol. 2012 Nov;27(11):2099-2106. doi: 10.1007/s00467-012-2217-6. Epub 2012 Jun 19.

  PMID: 22710694 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine and frozen pelvic tissue

MeSH Terms

Conditions

Ureteral Obstruction; Hydronephrosis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases

Study Officials

• Troels M Jørgensen, Professor, MD

  Department of Urology, Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 14, 2012

Record last verified: 2012-09

Locations

DK (1)