Patients With Renal Impairment and Diabetes Undergoing Co... | NCT00289614

Studies
Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)

NCT00289614

Sponsor

Bracco Diagnostics, Inc

Status

Completed

Last Update Posted

Jan 7, 2008Estimated

Enrollment

350Estimated

Phase

Phase 4

Conditions

Kidney Diseases

Interventions

Iopamidol 370 mgI/dL

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

Jan 2008

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

Jan 2006

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Feb 8, 2006

First Submission Date that Met QC Criteria

Feb 8, 2006

First Posted Date

Feb 10, 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

Jan 3, 2008

Last Update Posted Date

Jan 7, 2008Estimated

Description Module

Brief Summary

The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine 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

350Estimated

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase in serum creatinine (SCr) at 48-72 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Referred for contrast enhanced MDCT
Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2
Diagnosed as having diabetes mellitus

Exclusion Criteria:

Unstable renal function
Unstable diabetes
Concurrent administration of nephrotoxic drugs
Undergoing 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
Kathleen S Bensel, CNMT	Bracco Diagnostics, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bracco Diagnostics, Inc.		Princeton	New Jersey	08540	United States

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided