NCT00310557

Brief Summary

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the renal arteries. The results will be compared to the results of MRI taken without Magnevist and with the results of your X-ray angiography.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_3

Status
completed

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

December 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

First QC Date

March 31, 2006

Last Update Submit

December 28, 2014

Conditions

Renal Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • Accuracy, sensitivity and specificity based on quantitative assessment of stenosis

    Image creation after injection - evaluation at blind read

Secondary Outcomes (11)

  • Diagnostic confidence

    At blinded and/or open label read of images

  • Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses

    At blinded and/or open label read of images

  • Difference in degree of stenosis

    At blinded and/or open label read of images

  • Other diagnostic findings

    At blinded and/or open label read of images

  • Localisation matching of maximum stenosis

    At blinded and/or open label read of images

  • +6 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Gadopentetate dimeglumine (Magnevist)

Interventions

Gadopentetate dimeglumine (Magnevist)DRUG

Approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Artery Obstruction

Interventions

Gadolinium DTPA

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 4, 2006

Study Start

December 1, 2003

Study Completion

December 1, 2004

Last Updated

December 30, 2014

Record last verified: 2014-12