Ureteral ObstructionNCT00568724
Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis
An observational study of Ureteral Obstruction, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Ureteral Obstruction
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children referred to surgical treatment of congenital hydronephrosis caused by ureteral obstruction.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Clinical Medicine, University of Aarhus
Aarhus, 8200
About this study
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
- Medical subject headings
- Ureteral Obstruction, Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary cytokines
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureteral ObstructionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Troels M Jørgensen, Professor, MD, Principal investigator, Department of Urology, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568724
- Sponsor's protocol ID
- MGM-01
- Status last verified
- Sep 2012
- First submitted
- 5 Dec 2007
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22710694
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis
- ClinicalTrials.gov ID
- NCT00568724
- Acronym / sponsor ID
- MGM-01
- Conditions
- Ureteral Obstruction
- Keywords
- Hydronephrosis, Ureteral obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Nov 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children referred to surgical treatment of congenital hydronephrosis caused by ureteral obstruction.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary cytokines
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- Background: PubMed 22710694Madsen 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.
Related trials for Ureteral Obstruction
Not yet recruiting
Safety and Efficacy of Ultrasound-Guided Percutaneous Nephrostomy in Oncology Patients
Obstructive Uropathy, Hydronephrosis
Not yet recruitingObservational study
An Integrated Multi-omics Study on the Molecular Mechanisms of Ureteral Stricture
Ureteral Stricture, Ureteral Obstruction
Active, not recruitingObservational study
Radiomics and Image Segmentation of Urinary Stones by Artificial Intelligence
Urinary Stone, Renal Colic
Recruiting
Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction
Hydronephrosis; Obstruction, Ureter, Renal Failure
Recruiting
Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
Ureteral Stenosis, Hydronephrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troels M Jørgensen, Professor, MD principal investigator
Department of Urology, Aarhus University Hospital Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Obstruction, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary cytokines (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00568724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2012.