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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabete Mellitus; Congestive Heart Failure; Chronic Renal Insufficiency
• Intervention / Treatment: Drug: GE-145

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • GE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Medpace, Inc.; Biomedical Systems; i3 Statprobe; Rules-Based Medicine, Inc.
• Investigators: Study Director: Rubin Sheng, M.D., GE Healthcare

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 1, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: PCI Percutaneous coronary intervention; 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; SCr Serum creatinine
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Heart Failure; Diabetes Mellitus; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: GE 145-002