Renal Effects of Three Iodinated Contrast Media (CM) in P... | NCT00335101

Studies
Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography

NCT00335101

Sponsor

GE Healthcare

Status

Withdrawn

Last Update Posted

Apr 29, 2019Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Coronary Artery Disease (CAD)
Renal Impairment
Diabetes Mellitus

Interventions

Iodixanol, Ioversol, Iopromide

Countries

United States
Germany

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor Decision to withdraw study (comparative product withdrawn from the market)

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 6, 2006

First Submission Date that Met QC Criteria

Jun 6, 2006

First Posted Date

Jun 8, 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

Apr 25, 2019

Last Update Posted Date

Apr 29, 2019Actual

Description Module

Brief Summary

The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.

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

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Iodixanol, Ioversol, Iopromide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary endpoint:
Maximum peak increase in SCr from baseline up to day 3.
Secondary endpoints:
Change in SCr from baseline to day 2 and to day 3
Number of subjects with contrast-induced nephropathy (CIN)
Quality of diagnostic information

Secondary Outcomes

Measure	Description	Time Frame
Coronary Artery Disease (CAD)
Renal Impairment
Diabetes mellitus

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as SCr ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.

Exclusion Criteria:

Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplantation or with CrCl < 20 mL/min will not be included.

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
Marc Pignot, PhD	GE Healthcare	Study Director
Johnny Gibbs, Jr., CCRA	GE Healthcare	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GE Healthcare		Princeton	New Jersey	08540	United States
GE Healthcare

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D051437	Renal Insufficiency
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C044834	iodixanol
C054871	ioversol
C038192	iopromide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided