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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

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

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

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

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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