Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Renal Insufficiency, Diabete Mellitus, Congestive Heart Failure

Intervention / Treatment
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* Drug: GE-145


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GE 145 320mg I/ml injection<br> | Drug: GE-145<br>* GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.<br>* Other names: Ioforminol;|
| Active Comparator: Iopamidol 370mg I/ml injection<br> | Drug: GE-145<br>* GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.<br>* Other names: Ioforminol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After the imaging date for either Ioforminol or Iopamidol. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration. | 
| 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). | 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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