CLINICAL TRIALS PROFILE FOR IOPAMIDOL-300

All Clinical Trials for Iopamidol-300

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.

Clinical Trial Conditions for Iopamidol-300

Condition Name

Condition Name for Iopamidol-300
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2
Percutaneous Coronary Intervention	1

Condition MeSH

Condition MeSH for Iopamidol-300
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3
Kidney Diseases	3

Clinical Trial Locations for Iopamidol-300

Trials by Country

Trials by Country for Iopamidol-300
Location	Trials
United States	20
Italy	2
China	2
Canada	2
Singapore	1

Trials by US State

Trials by US State for Iopamidol-300
Location	Trials
New Jersey	10
California	2
North Carolina	2
Illinois	2
Texas	1

Clinical Trial Progress for Iopamidol-300

Clinical Trial Phase

Clinical Trial Phase for Iopamidol-300
Clinical Trial Phase	Trials
Phase 4	16
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Iopamidol-300
Clinical Trial Phase	Trials
Completed	15
Terminated	5
Recruiting	5

Clinical Trial Sponsors for Iopamidol-300

Sponsor Name

Sponsor Name for Iopamidol-300
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for Iopamidol-300
Sponsor	Trials
Industry	27
Other	22
NIH	2

Iopamidol-300: Clinical Trials, Market Analysis, and Projections

Introduction to Iopamidol-300

Iopamidol-300 is a non-ionic iodinated contrast agent widely used in various medical imaging procedures, including computed tomography (CT) scans, angiography, and excretory urography. Its high water solubility, low osmolality, and non-ionic nature make it a safe and effective choice for enhancing the visibility of internal structures during diagnostic imaging.

Clinical Trials and Safety Profile

Visualization and Safety

Clinical studies have demonstrated that iopamidol-300 provides visualization nearly equivalent to that of other contrast agents like Urografin, with a 19% better pyelogram, especially in the calix region[1]. In a study involving 21 elderly patients, iopamidol-300 showed no side effects or adverse reactions, and no abnormalities were noted in serum chemistries. This highlights its safety profile, particularly in older patients[1].

Renal Function Impact

A comparative study between iohexol and iopamidol-300 evaluated their effects on renal function in outpatients undergoing CT scans. The results indicated that both contrast agents had minimal impact on serum creatinine levels, with no statistically significant difference in contrast-induced nephropathy rates. This suggests that iopamidol-300 is as safe as other commonly used contrast agents in terms of renal function[4].

Market Analysis

Market Size and Growth

The global iopamidol injection market is projected to experience significant growth. From 2022 to 2028, the market is expected to grow from approximately $1.5 billion to around $2.5 billion, with a compound annual growth rate (CAGR) of around 7.4%[3]. By 2033, the market is forecasted to reach a value of USD XXX million, expanding at a CAGR of XX% during the forecast period from 2025 to 2033[2].

Key Drivers

The growth of the iopamidol injection market is driven by several factors:

• Increasing Prevalence of Chronic Diseases: Conditions such as cardiovascular and kidney diseases require frequent imaging tests, boosting the demand for contrast agents like iopamidol-300[2][3].
• Advancements in Radiology: Technological innovations in imaging systems and the growing adoption of advanced imaging techniques like CT and MRI are driving market growth[2][3].
• Rising Demand for Minimally Invasive Procedures: The increasing use of iopamidol injection in procedures such as angioplasty and coronary angiography is a significant market driver[2].

Competitive Landscape

The market is characterized by the presence of several key players, including Bracco Imaging, Sanochemia, Consentis, T2Pharma, Bayer, Takeda, Fuji Pharma, Hikari Pharmaceutical, and BeiLu Pharma. These companies are focusing on developing and commercializing innovative iopamidol-based contrast agents with improved safety profiles and enhanced imaging capabilities[2].

Regional Analysis

North America is expected to dominate the market, capturing approximately 40% of the market share, followed by Europe. The Asia-Pacific region is anticipated to grow rapidly, contributing about 20% of the market share. Emerging markets, particularly in the Asia-Pacific region, present significant opportunities for future expansion[3].

Market Trends

Shift to Safer Contrast Agents

There is a growing trend towards the development and use of safer and more efficient contrast agents. Iopamidol-300, with its non-ionic nature and low osmolality, aligns well with this trend, enhancing its market penetration[3].

Technological Innovations

Advancements in formulation technologies and imaging systems are enhancing the market opportunities for iopamidol-300. The integration of advanced imaging techniques and the development of new contrast agents with improved safety and efficacy profiles are key trends shaping the market[2][3].

Growing Demand in Emerging Markets

The increasing healthcare expenditure and improved imaging infrastructure in emerging markets, particularly in the Asia-Pacific region, are driving the demand for iopamidol-300. This region is expected to witness the fastest growth during the forecast period[3].

Product Insights

Concentration and Formulations

Iopamidol-300 is available in various concentrations, including 300 mg/mL, 370 mg/mL, and 400 mg/mL. The product is offered in different formulations such as isotonic and hypertonic solutions, catering to various clinical needs[2].

Applications

Iopamidol-300 is commonly used in computed tomography (CT) scans to enhance the visibility of blood vessels, organs, and other internal structures. It is also used in angiography, coronary angiography, and excretory urography, among other imaging procedures[2][3].

Key Takeaways

• Clinical Safety: Iopamidol-300 has a strong safety profile, with minimal adverse effects and no significant impact on renal function.
• Market Growth: The global iopamidol injection market is projected to grow significantly, driven by increasing diagnostic imaging procedures and technological advancements.
• Regional Dominance: North America is expected to dominate the market, with the Asia-Pacific region showing rapid growth.
• Trends: The market is shifting towards safer and more efficient contrast agents, with a growing demand in emerging markets.

FAQs

What is the primary use of iopamidol-300 in medical imaging?

Iopamidol-300 is primarily used as a contrast agent in computed tomography (CT) scans, angiography, and other imaging procedures to enhance the visibility of internal structures.

What are the key drivers of the iopamidol injection market?

The key drivers include the increasing prevalence of chronic diseases, advancements in radiology, and the growing demand for minimally invasive procedures.

Which region is expected to dominate the iopamidol injection market?

North America is expected to dominate the market, capturing approximately 40% of the market share.

What are the common concentrations of iopamidol injection?

Iopamidol injection is available in concentrations of 300 mg/mL, 370 mg/mL, and 400 mg/mL.

How does iopamidol-300 compare to other contrast agents in terms of renal function impact?

Iopamidol-300 has been shown to have a minimal impact on renal function, similar to other commonly used contrast agents like iohexol, making it a safe choice for patients undergoing CT scans.

Sources

1. Clinical studies with a new non-ionic contrast medium (iopamidol ... - PubMed.
2. Strategic Vision for iopamidol injection Market Expansion - Data Insights Market.
3. Iopamidol Injection Market, Global Outlook and Forecast 2022-2028 - Reliable Market Forecast.
4. Comparative investigation of IV iohexol and iopamidol: Effect on ... - MD Anderson Staging.
5. Iopamidol Injection Market Report 2024 (Global Edition) - Cognitive Market Research.