CLINICAL TRIALS PROFILE FOR ISOVUE-200

All Clinical Trials for Isovue-200

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX-CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Averion International Corporation	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Covance	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Clinical Trial Conditions for Isovue-200

Condition Name

Condition Name for Isovue-200
Intervention	Trials
Peripheral Arterial Occlusive Disease	2
Diabetes Mellitus	2
Drug Safety	1
Healthy	1

Condition MeSH

Condition MeSH for Isovue-200
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Diabetes Mellitus	2
Coronary Artery Disease	2

Clinical Trial Locations for Isovue-200

Trials by Country

Trials by Country for Isovue-200
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for Isovue-200
Location	Trials
New Jersey	11
California	1
North Carolina	1
Alabama	1
New York	1

Clinical Trial Progress for Isovue-200

Clinical Trial Phase

Clinical Trial Phase for Isovue-200
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Isovue-200
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Isovue-200

Sponsor Name

Sponsor Name for Isovue-200
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Duke University	2

Sponsor Type

Sponsor Type for Isovue-200
Sponsor	Trials
Industry	21
Other	9
NIH	1

ISOVUE-200: Clinical Trials, Market Analysis, and Projections

Introduction

ISOVUE-200, a formulation of iopamidol injection, is a nonionic radiographic contrast agent widely used in various radiological procedures. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Safety Profile

ISOVUE-200 has been extensively studied in clinical trials to establish its safety and efficacy. Here are some key findings:

Adverse Reactions

Clinical studies involving about 2246 patients have shown that ISOVUE-200 has a relatively low incidence of adverse reactions. The estimated overall incidence of reactions includes transient changes in vital signs and hemodynamic parameters, but these are generally mild and temporary[1][3][4].

Pediatric Use

In a clinical trial involving 76 pediatric patients undergoing angiocardiography, only 2 adverse reactions (2.6%) were remotely attributed to the contrast media. This suggests that ISOVUE-200 is relatively safe for use in pediatric patients[4].

Contraindications

ISOVUE-200 is contraindicated in patients with known hypersensitivity to the product and in those with significant impairment of both renal and hepatic functions. It is also not recommended for intrathecal administration or use with corticosteroids[3].

Indications and Usage

ISOVUE-200 is indicated for a wide range of radiological procedures, including:

Angiography

ISOVUE-200 is used for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography, and ventriculography[1][2][4].

Computed Tomographic Imaging

It enhances computed tomographic brain and body imaging, particularly useful for refining diagnostic precision in areas that may not otherwise be satisfactorily visualized[1][2][4].

Excretory Urography

ISOVUE-200 is also recommended for intravenous excretory urography in both adults and children[1][3][4].

Pharmacokinetics and Pharmacodynamics

Distribution and Elimination

Following intravascular administration, iopamidol is immediately diluted in the circulating plasma and distributed between the circulating blood volume and other extracellular fluid compartments. It does not significantly bind to serum or plasma proteins and does not cross the blood-brain barrier to any significant extent[1][2][4].

Contrast Enhancement

The degree of enhancement of tissue density is directly related to the iodine content in the administered dose. Maximum contrast enhancement frequently occurs after peak blood iodine levels are reached, typically within 5 to 15 minutes after administration[2][4].

Market Analysis

Market Presence

ISOVUE-200 has been well established in the U.S. market since 1986 and has a significant global presence, with over 250 million doses of iopamidol administered worldwide[5].

Vendor Focus on Patient Safety

The manufacturer, Bracco, has emphasized optimizing patient safety with ISOVUE. The drug is known for its lower osmolality compared to ionic contrast agents, which results in less discomfort and diuresis for patients[3][5].

Packaging and Efficiency

ISOVUE Multipack Pharmacy Bulk package offers multi-dosing efficiency in 200 mL and 500 mL volumes, making it a convenient option for healthcare providers[5].

Market Projections

Growing Demand for Diagnostic Procedures

The demand for diagnostic imaging procedures is expected to increase due to the rising prevalence of chronic diseases and the need for early diagnosis. This trend is likely to drive the market for contrast agents like ISOVUE-200[5].

Technological Advancements

Advancements in imaging technologies, such as dynamic computed tomographic imaging, will continue to enhance the utility of ISOVUE-200, potentially expanding its market share[4].

Competitive Landscape

The market for nonionic contrast agents is competitive, but ISOVUE-200's established safety profile, flexibility in usage, and wide range of iodine concentrations position it favorably against other competitors[5].

Key Takeaways

• Clinical Safety: ISOVUE-200 has a favorable safety profile with low incidence of adverse reactions.
• Versatile Indications: It is indicated for a wide range of radiological procedures, including angiography and computed tomographic imaging.
• Pharmacokinetics: Iopamidol is distributed in extracellular fluid compartments and does not significantly bind to plasma proteins.
• Market Presence: Established in the U.S. since 1986 with over 250 million doses administered globally.
• Future Projections: Expected to benefit from growing demand for diagnostic procedures and technological advancements in imaging.

FAQs

What are the common indications for ISOVUE-200?

ISOVUE-200 is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography, and ventriculography, as well as for computed tomographic brain and body imaging and intravenous excretory urography[1][2][4].

What are the contraindications for ISOVUE-200?

ISOVUE-200 is contraindicated in patients with known hypersensitivity to the product and in those with significant impairment of both renal and hepatic functions. It is also not recommended for intrathecal administration or use with corticosteroids[3].

How does ISOVUE-200 compare to ionic contrast agents?

ISOVUE-200 has lower osmolality compared to ionic contrast agents, resulting in less discomfort and diuresis for patients. It also generally causes less pain or warmth during peripheral arteriography[3].

What is the typical dosage and administration of ISOVUE-200?

The dosage and administration of ISOVUE-200 vary depending on the specific procedure. For example, ISOVUE-200 is recommended for peripheral venography in adults, while ISOVUE-300 and ISOVUE-370 are recommended for other specific procedures[1][3][4].

How safe is ISOVUE-200 for pediatric patients?

ISOVUE-200 has been shown to be relatively safe for use in pediatric patients, with only a few adverse reactions reported in clinical trials[4].

What are the packaging options available for ISOVUE-200?

ISOVUE Multipack Pharmacy Bulk package offers multi-dosing efficiency in 200 mL and 500 mL volumes, making it a convenient option for healthcare providers[5].

Sources

1. ISOVUE® (Iopamidol Injection) - accessdata.fda.gov
2. iopamidol injection, solution ISOVUE 200 - DailyMed
3. IsovueTM Iopamidol Injection USP (41%, 61%, and 76% w/v) - e-lactancia.org
4. ISOVUE® (Iopamidol Injection) - accessdata.fda.gov (2023)
5. Bracco Puts on View Contrast Media Isovue - itnonline.com