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GE-145

Phase 2

Chronic Renal Insufficiency | Small molecule | Cardiovascular |GE HealthCare Technologies Inc.|Trials Updated: Aug 29, 2018

GE-145 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Oct 2009

GE-145 target and mechanism

ModalitySmall molecule

Also known as GE-145 (AN113111) Injection, Ioforminol, AH113111

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment284

FDA Designations

No designations recorded

GE-145 clinical trials

GE-145 · 1 trial · 3 indications

Phase 2 1
NCT01252810Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary ProcedureChronic Renal Insufficiency
COMPLETED284 Analytics
PHASE2COMPLETED
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Chronic Renal InsufficiencyUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
After the imaging date for either Ioforminol or Iopamidol.

Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.

Secondary Endpoints

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
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
2, 6 and 24 hours post Ioforminol and Iopamidol adminstration
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
GE 145 320mg I/ml injectionEXPERIMENTAL -
Iopamidol 370mg I/ml injectionACTIVE_COMPARATOR -

Interventions

NameTypeDescription
GE-145DRUGGE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 accor...

Countries:United States
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Frequently asked questions about GE-145

What is GE-145?

GE-145 is an investigational small molecule contrast agent being developed by GE HealthCare Technologies Inc. for use in imaging procedures. It is formulated as an injectable agent and has been studied in patients with chronic renal insufficiency, a condition in which kidney function is reduced. GE-145 is also known as GE-145 (AN113111) Injection.

What is GE-145 used for in chronic renal insufficiency?

GE-145 is being studied as an injectable contrast agent for imaging in patients with chronic renal insufficiency. Its development focuses on use during coronary procedures in patients whose reduced kidney function makes contrast selection important. The Phase 2 program enrolled patients with chronic renal insufficiency, diabetes mellitus, and congestive heart failure.

Who makes GE-145?

GE-145 is developed by GE HealthCare Technologies Inc., which trades on the Nasdaq under the ticker GEHC. The company is the sponsor of the clinical program evaluating the agent. GE-145 is also referred to as GE-145 (AN113111) Injection.

What phase is GE-145 in?

GE-145 is in Phase 2 development. It is an investigational agent and has not been approved by the FDA. The Phase 2 study evaluating GE-145 has been completed, and no trials of the agent are currently listed as active.

What clinical trials is GE-145 in?

GE-145 has been evaluated in one completed Phase 2 trial, NCT01252810, titled Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure. The randomized, double-blind, active-controlled study enrolled 284 participants aged 65 years and older in the United States.

Is GE-145 the same as GE-145 (AN113111) Injection?

Yes. GE-145 (AN113111) Injection is an alternative name for GE-145, the investigational contrast agent developed by GE HealthCare Technologies Inc. Both names refer to the same small molecule program studied in patients with chronic renal insufficiency undergoing coronary procedures.