NCT00585767

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2001

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

12.1 years

First QC Date

December 26, 2007

Last Update Submit

May 25, 2017

Conditions

Keywords

Hydronephrosis

Study Arms (2)

1

Patients with two kidneys

2

Patients with solitary kidney

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed with obstructive uropathy

You may qualify if:

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

You may not qualify if:

  • Patients with known or suspected hypersensitivity to gadolinium-based agents.
  • Patients who are pregnant or lactating.
  • Patients with a condition that is a contraindication 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 (creatinine clearance \<10 ml/min or serum creatinine \>1.8 mg/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Richard Katzburg, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 3, 2008

Study Start

April 1, 2001

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 30, 2017

Record last verified: 2017-05