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

NCT01252810 | Completed Phase 2 Results DMC

• 1 other identifier: GE 145-002
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

GE 145 320mg I/ml injection

EXPERIMENTAL

Drug: GE-145

Iopamidol 370mg I/ml injection

ACTIVE COMPARATOR

Drug: GE-145

Interventions

GE-145 DRUG

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

Also known as: Ioforminol

GE 145 320mg I/ml injection; Iopamidol 370mg I/ml injection

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• \) 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;
• \) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
• \) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• i3 Statprobe: collaborator
• Medpace, Inc.: collaborator
• Biomedical Systems: collaborator
• Rules-Based Medicine, Inc.: collaborator

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Heart Failure

Interventions

5-(formyl-(3-(formyl-(3,5-bis (2,3-dihydroxypropylcarbamoyl)-2,4,6-triiodophenyl) amino)-2-hydroxypropyl)amino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ruben Sheng, M.D.
• Organization: GE Healthcare

Rubin.Sheng@ge.com

609-514-6899

Study Officials

• Rubin Sheng, M.D.

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 29, 2018
• Results First Posted: May 2, 2014

Record last verified: 2018-08

Locations

US (1)