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WithdrawnNCT00585767Updated May 30, 2017

Functional, Dynamic, and Anatomic MR Urography

An observational study in Hydronephrosis, sponsored by University of California, Davis. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by University of California, Davis · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

This is a clinical feasibility study to assess the value of MR imaging for obtaining functional, dynamic and anatomical information in a comprehensive imaging protocol in subjects having obstructive uropathy.

02

Conditions studied

  • Hydronephrosis

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Keywords

  • Hydronephrosis
03

In context

Hydronephrosis

55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.

Browse Hydronephrosis studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have been diagnosed with obstructive uropathy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males or females 18 years of age or older.
  • All female patients of must agree to use a medically accepted method of at the time of the study.
  • Patients must have the ability to understand the requirements of the study, provide written and to participate, and agree to abide by the study requirements.
  • Patients who have known or suspected hydronephrosis or patients with solitary kidneys.

Exclusion criteria

Exclusion Criteria:

  • Patients with known or suspected to gadolinium-based agents.
  • Patients who are pregnant or lactating.
  • Patients with a condition that is a to MRI (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other conditions that would preclude patient proximity to a strong external magnetic field).
  • Patients with a recent history of hemolytic anemia, sickle cell anemia or other hemoglobinopathy.
  • Patients with a history of significant claustrophobia.
  • Patients with impaired renal function based on 24-hr urine collection ( \<10 ml/min or serum creatinine >1.8 mg/dl)
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • 1

    Patients with two kidneys

  • 2

    Patients with solitary kidney

06

Study locations

No study locations are listed for this record.

07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2001, a primary completion of May 2013 and a completion of May 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 26, 2007
First posted
Jan 3, 2008
Start
Apr 2001
Primary completionEst.
May 2013
CompletionEst.
May 2013
Last update
May 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00585767
Responsible party
Sponsor
First posted
Jan 3, 2008
Start date
Apr 2001
Primary completion
May 2013 (estimated)
Completion
May 2013 (estimated)
Last update
May 30, 2017

Study contacts

Richard Katzburg, MD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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