Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Primary Purpose
Chronic Renal Insufficiency, Diabete Mellitus, Congestive Heart Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GE-145
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Renal Insufficiency focused on measuring CATH Catheterization, CI-AKI Contrast-induced acute kidney injury, DM Diabetes mellitus, eGFR Estimated glomerular filtration rate, MDRD Modification of Diet in Renal Disease, NYHA New York Heart Association, PCI Percutaneous coronary intervention, SCr Serum creatinine
Eligibility Criteria
Inclusion Criteria:
- Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
- The subject has at least one of the following comorbidities:
- 1) Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
- 2) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
- 3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.
Exclusion Criteria:
- The subject has known allergies to either iodine or any ICM.
- The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
- The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
- The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.
Sites / Locations
- GE Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GE 145 320mg I/ml injection
Iopamidol 370mg I/ml injection
Arm Description
Outcomes
Primary Outcome Measures
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.
Secondary Outcome Measures
To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration
To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol.
To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol.
Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections
Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).
Full Information
NCT ID
NCT01252810
First Posted
December 1, 2010
Last Updated
August 1, 2018
Sponsor
GE Healthcare
Collaborators
i3 Statprobe, Medpace, Inc., Biomedical Systems, Rules-Based Medicine, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01252810
Brief Title
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Official Title
A Phase 2, Double-Blind, Randomized, Safety Study of GE-145 320 mg I/mL Injection Versus Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Artery Catheterization Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
i3 Statprobe, Medpace, Inc., Biomedical Systems, Rules-Based Medicine, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Insufficiency, Diabete Mellitus, Congestive Heart Failure
Keywords
CATH Catheterization, CI-AKI Contrast-induced acute kidney injury, DM Diabetes mellitus, eGFR Estimated glomerular filtration rate, MDRD Modification of Diet in Renal Disease, NYHA New York Heart Association, PCI Percutaneous coronary intervention, SCr Serum creatinine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GE 145 320mg I/ml injection
Arm Type
Experimental
Arm Title
Iopamidol 370mg I/ml injection
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
GE-145
Other Intervention Name(s)
Ioforminol
Intervention Description
GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
Primary Outcome Measure Information:
Title
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
Description
Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.
Time Frame
After the imaging date for either Ioforminol or Iopamidol.
Secondary Outcome Measure Information:
Title
To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration
Description
To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol.
To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol.
Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.
Time Frame
Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.
Title
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections
Description
Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).
Time Frame
2, 6 and 24 hours post Ioforminol and Iopamidol adminstration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
The subject has at least one of the following comorbidities:
1) Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
2) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.
Exclusion Criteria:
The subject has known allergies to either iodine or any ICM.
The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubin Sheng, M.D.
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GE Healthcare
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
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