CLINICAL TRIALS PROFILE FOR ISOVUE-128

All Clinical Trials for Isovue-128

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.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Examination Management Services Inc.	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	Quintiles, Inc.	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	GE Healthcare	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-128

Condition Name

Condition Name for Isovue-128
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Malignant Lung Neoplasm	1
Stage IV Lung Cancer	1

Condition MeSH

Condition MeSH for Isovue-128
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Arterial Occlusive Diseases	2
Myocardial Ischemia	2

Clinical Trial Locations for Isovue-128

Trials by Country

Trials by Country for Isovue-128
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for Isovue-128
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for Isovue-128

Clinical Trial Phase

Clinical Trial Phase for Isovue-128
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Isovue-128
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Isovue-128

Sponsor Name

Sponsor Name for Isovue-128
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
i3 Statprobe	2

Sponsor Type

Sponsor Type for Isovue-128
Sponsor	Trials
Industry	21
Other	9
NIH	1

Isovue-128: Clinical Trials, Market Analysis, and Projections

Introduction

Isovue-128, a formulation of the non-ionic radiographic contrast agent iopamidol, is 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 Efficacy

Indications and Usage

Isovue-128 is indicated for several intravascular procedures, including peripheral venography, peripheral arteriography, cerebral arteriography, excretory urography, and intravenous contrast enhancement in computed tomography (CT) of the head and body[2][5].

Clinical Studies

Clinical studies involving iopamidol formulations, such as Isovue-128, have shown its efficacy in providing clear contrast for diagnostic imaging. These studies have involved approximately 2246 patients and have demonstrated the drug's ability to opacify vessels and enhance CT imaging, particularly in areas such as the brain, kidneys, and abdominal cavity[1].

Safety Profile

The safety profile of Isovue-128 is generally favorable, with lower osmolality compared to ionic contrast agents, resulting in less discomfort and diuresis. However, it is contraindicated in patients with known hypersensitivity to the product and those with significant impairment of both renal and hepatic functions. Special precautions are advised in patients with increased intracranial pressure, cerebral thrombosis, or other conditions where the blood-brain barrier is compromised[2].

Adverse Reactions

Adverse reactions to Isovue-128 are relatively rare but can include pain, warmth, or other transient changes. The estimated overall incidence of adverse reactions is based on clinical studies, and the drug is generally well-tolerated[1].

Market Analysis

Market Position

Isovue-128 competes in the market of non-ionic radiographic contrast agents, which is a segment of the broader diagnostic imaging market. The market is driven by the increasing demand for diagnostic procedures, advancements in imaging technologies, and the preference for non-ionic agents due to their lower osmolality and reduced side effects[5].

Competitors

Key competitors in the market include other non-ionic contrast agents such as Omnipaque (iohexol) and Visipaque (iodixanol). These agents also offer similar benefits in terms of lower osmolality and reduced adverse reactions, making the market highly competitive[3].

Market Trends

The diagnostic imaging market is trending towards the use of low-osmolar and isosmolar contrast agents due to their better safety profiles. The increasing prevalence of chronic diseases and the need for early diagnosis are driving the demand for these agents. Additionally, advancements in CT and MRI technologies are further boosting the market[5].

Market Projections

Growth Potential

The market for non-ionic radiographic contrast agents, including Isovue-128, is expected to grow steadily over the next few years. This growth is driven by the increasing need for diagnostic imaging in healthcare, particularly in aging populations and in regions with rising healthcare standards[5].

Regional Analysis

The market for Isovue-128 is expected to see significant growth in regions such as North America, Europe, and Asia-Pacific. These regions have advanced healthcare systems and a high demand for diagnostic imaging procedures. Emerging markets are also expected to contribute to the growth as healthcare infrastructure improves[5].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as regulatory scrutiny, competition from other contrast agents, and the need for continuous innovation to stay ahead. Opportunities exist in expanding into new markets, developing new formulations, and integrating with advanced imaging technologies[3].

Regulatory Considerations

FDA Classification

Isovue-128 is classified under FDA Pregnancy Category B, indicating that animal reproduction studies have failed to demonstrate a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women[4].

Contraindications and Precautions

The drug is contraindicated in patients with known hypersensitivity and significant impairment of both renal and hepatic functions. Special precautions are necessary in patients with renal insufficiency, increased intracranial pressure, and other critical conditions[2].

Key Takeaways

• Clinical Efficacy: Isovue-128 is effective in various radiological procedures, providing clear contrast for diagnostic imaging.
• Safety Profile: The drug has a favorable safety profile with lower osmolality and reduced adverse reactions compared to ionic agents.
• Market Position: Isovue-128 competes in the market of non-ionic radiographic contrast agents, driven by demand for diagnostic procedures and advancements in imaging technologies.
• Growth Potential: The market is expected to grow steadily, driven by the increasing need for diagnostic imaging and advancements in healthcare.
• Regulatory Considerations: The drug is classified under FDA Pregnancy Category B and has specific contraindications and precautions.

FAQs

What are the primary indications for Isovue-128?

Isovue-128 is indicated for peripheral venography, peripheral arteriography, cerebral arteriography, excretory urography, and intravenous contrast enhancement in computed tomography (CT) of the head and body[2].

What are the common adverse reactions to Isovue-128?

Common adverse reactions include pain, warmth, or other transient changes. The drug is generally well-tolerated, but serious reactions can occur in patients with specific conditions[1].

Can Isovue-128 be used in pregnant women?

Use of Isovue-128 in pregnant women is not recommended unless clearly needed. It is classified under FDA Pregnancy Category B, indicating no proven risk in humans but lacking adequate studies in pregnant women[4].

How does Isovue-128 compare to other non-ionic contrast agents?

Isovue-128 competes with other non-ionic agents like Omnipaque and Visipaque, offering similar benefits of lower osmolality and reduced adverse reactions. The choice between these agents often depends on specific patient needs and procedural requirements[3].

What are the future market projections for Isovue-128?

The market for Isovue-128 is expected to grow steadily, driven by the increasing demand for diagnostic imaging and advancements in healthcare technologies. Growth is anticipated in regions with advanced healthcare systems and emerging markets[5].

References

1. ISOVUE® (Iopamidol Injection) Label - FDA.
2. IsovueTM Iopamidol Injection USP - Bracco Diagnostics Inc.
3. Case 3:03-cv-06025-FLW-TJB Document 625 - GovInfo.
4. Iopamidol Use During Pregnancy - Drugs.com.
5. Iopamidol | Drug Information, Uses, Side Effects, Chemistry - PharmaCompass.