Renal MRA Crossover Study Comparing Multihance to Another... | NCT00415805

Studies
Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

NCT00415805

Sponsor

Bracco Diagnostics, Inc

Status

Completed

Last Update Posted

Aug 1, 2023Actual

Enrollment

39Actual

Phase

Phase 3

Conditions

Steno-occlusive Disease

Interventions

Multihance
vasovist

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Dec 22, 2006

First Submission Date that Met QC Criteria

Dec 23, 2006

First Posted Date

Dec 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2023

Last Update Posted Date

Aug 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Multihance
2	Active Comparator		Drug: vasovist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multihance	Drug	0.5 Molar, single injection at 0.2 mL/kg	1
vasovist

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity compared to DSA		post dose

Secondary Outcomes

Measure	Description	Time Frame
accuracy and predictive values; inter-reader agreement for diagnostic performance		post dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Known or suspected renovascular disease based on one of the following criteria:
- severe hypertension
- hypertension refractory to standard therapy
- abrupt onset of moderate to severe hypertension at age < 35 years
- normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension
- unexplained by stable elevation of serum creatinine > 2Mg/dL
- positive findings for stenosis from another imaging modality

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gianpaolo Pirovano, MD	Bracco Diagnostics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bracco Imaging, S.p.A		Milan		20134	Italy

Intervention Browse Module

MeSH Terms

ID	Term
C064572	gadobenic acid
C109932	gadofosveset trisodium

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided