Patients With Renal Impairment Undergoing CT | NCT00292487

Studies
Patients With Renal Impairment Undergoing CT

NCT00292487

Sponsor

Bracco Diagnostics, Inc

Status

Completed

Last Update Posted

Feb 8, 2012Estimated

Enrollment

150

Phase

Phase 4

Conditions

Contrast Induced Nephropathy

Interventions

Iopamidol 370 mgI/mL

Countries

United States

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

Aug 2006

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

Nov 2004

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Feb 14, 2006

First Submission Date that Met QC Criteria

Feb 14, 2006

First Posted Date

Feb 16, 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

Feb 7, 2012

Last Update Posted Date

Feb 8, 2012Estimated

Description Module

Brief Summary

The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
Iopamidol 370 mgI/mL	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase in SCr at 48-72 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Compare incidence of delayed hypersensitivity type reactions
Compare changes in heart rate
Compare efficacy of key vessels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

referred for MDCT of liver or peripheral CTA
stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min

Exclusion Criteria:

unstable renal function
required prophylactic drugs to receive contrast (other than hydration)
uncontrolled diabetes
currently on dialysis

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
Marie Morris	Bracco Diagnostics, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bracco Diagnostics, Inc		Princeton	New Jersey	08543	United States