CLINICAL TRIALS PROFILE FOR IOPAMIDOL-370

All Clinical Trials for Iopamidol-370

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.

Clinical Trial Conditions for Iopamidol-370

Condition Name

Condition Name for Iopamidol-370
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2

Condition MeSH

Condition MeSH for Iopamidol-370
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3

Clinical Trial Locations for Iopamidol-370

Trials by Country

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Trials by Country for Iopamidol-370
Location	Trials
United States	20
Italy	2
China	2
Canada	2
Singapore	1

Trials by US State

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−

Trials by US State for Iopamidol-370
Location	Trials
New Jersey	10
California	2
North Carolina	2
Illinois	2
Texas	1

Clinical Trial Progress for Iopamidol-370

Clinical Trial Phase

Clinical Trial Phase for Iopamidol-370
Clinical Trial Phase	Trials
Phase 4	16
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Iopamidol-370
Clinical Trial Phase	Trials
Completed	15
Terminated	5
Recruiting	5

Clinical Trial Sponsors for Iopamidol-370

Sponsor Name

Sponsor Name for Iopamidol-370
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for Iopamidol-370
Sponsor	Trials
Industry	27
Other	22
NIH	2

Iopamidol-370: Clinical Trials, Market Analysis, and Projections

Introduction to Iopamidol-370

Iopamidol-370 is a non-ionic, low-osmolar contrast agent commonly used in various diagnostic imaging procedures, including computed tomography (CT) scans. It is known for its high water solubility and low osmolality, making it a safe and effective choice for enhancing the visibility of blood vessels, organs, and other structures within the body.

Clinical Trials Overview

PREDICT Study

One of the significant clinical trials involving iopamidol-370 is the PREDICT study. This multicenter, double-blind, randomized study compared the incidence of contrast-induced nephropathy (CIN) between iopamidol-370 and iodixanol-320 in 248 patients with moderate-to-severe chronic kidney disease and diabetes mellitus. The study found no statistically significant difference in the rate of CIN between the two contrast agents, indicating that iopamidol-370 is as safe as iodixanol-320 in high-risk patients undergoing CT scans[1].

IMPACT Study

The IMPACT study is another notable clinical trial that compared the efficacy and safety of iopamidol-370 and iodixanol-320 in contrast-enhanced, multidetector-row computed tomography (CE-MDCT). This study involved 166 patients and found that iopamidol-370 provided significantly greater enhancement during the arterial phase and similar enhancement during the portal venous phase compared to iodixanol-320. The study also showed that the effects on heart rate (HR) of both contrast agents were similar[3].

Market Analysis

Market Size and Growth

The global iopamidol injection market, which includes iopamidol-370, is projected to experience significant growth in the coming years. According to market forecasts, the global iopamidol injection market is expected to grow from USD 1.8 billion in 2022 to USD 2.6 billion by 2027, at a Compound Annual Growth Rate (CAGR) of 7.0% during the forecast period. By 2033, the market is projected to reach a value of several billion dollars, although exact figures vary by source[2][5].

Key Drivers

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

• Increasing Prevalence of Chronic Diseases: The rising incidence of chronic diseases such as cardiovascular and kidney diseases, which require imaging tests for diagnosis and monitoring, is a significant driver.
• Growing Demand for Minimally Invasive Procedures: The increasing adoption of minimally invasive procedures, such as angioplasty and coronary angiography, which often use iopamidol-370, is another key factor.
• Advancements in Imaging Techniques: The development and adoption of advanced imaging techniques like CT and MRI also contribute to the market growth[2].

Competitive Landscape

The iopamidol injection 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. Strategic collaborations and acquisitions are also common strategies to expand product portfolios and gain a competitive edge[2].

Regional Analysis

North America is expected to dominate the iopamidol injection market during the forecast period due to the high prevalence of chronic diseases, well-established healthcare infrastructure, and the increasing adoption of advanced imaging techniques in the region. The cardiovascular applications segment is anticipated to be the dominant segment, driven by the high prevalence of cardiovascular diseases and the increasing use of iopamidol-370 for imaging procedures like angiography and coronary angiography[2].

Market Projections

Future Trends

Several trends are expected to shape the future of the iopamidol injection market:

• Development of New Contrast Agents: The development of new contrast agents with improved safety and efficacy profiles is a key trend.
• Increasing Use in Minimally Invasive Procedures: The growing use of iopamidol-370 in minimally invasive procedures will continue to drive market growth.
• Emerging Markets: The increasing demand for iopamidol injection in emerging markets is another significant trend[2].

Challenges and Restraints

Despite the positive outlook, the market faces several challenges:

• High Cost: The high cost of iopamidol injection is a significant restraint.
• Risk of Adverse Events: The risk of adverse events such as allergic reactions and renal toxicity is another challenge.
• Competition from Other Contrast Agents: Competition from other contrast agents also poses a challenge to the market growth[2].

Product Insights

Concentration and Characteristics

Iopamidol-370 is available in various concentrations, including 300 mg/mL, 370 mg/mL, and 400 mg/mL. Its high water solubility, low osmolality, and non-ionic nature make it a safe and effective contrast agent for a variety of imaging procedures[2].

Formulations

Iopamidol injection is available in different formulations, such as isotonic solutions, hypertonic solutions, and specific products like Isopaque 300, Isopaque 370, and Isopaque 400[2].

Key Takeaways

• Clinical Safety: Iopamidol-370 has been shown to be as safe as iodixanol-320 in high-risk patients in terms of CIN.
• Enhancement Efficacy: It provides significantly greater enhancement during the arterial phase compared to iodixanol-320.
• Market Growth: The global iopamidol injection market is expected to grow significantly, driven by the increasing prevalence of chronic diseases and advancements in imaging techniques.
• Competitive Landscape: The market is competitive with several key players focusing on innovative products and strategic collaborations.
• Future Trends: Development of new contrast agents, increasing use in minimally invasive procedures, and growing demand in emerging markets are key trends.

FAQs

What is the primary use of iopamidol-370?

Iopamidol-370 is primarily used as a contrast agent in computed tomography (CT) scans to enhance the visibility of blood vessels, organs, and other structures within the body.

What were the findings of the PREDICT study regarding iopamidol-370?

The PREDICT study found no statistically significant difference in the rate of contrast-induced nephropathy (CIN) between iopamidol-370 and iodixanol-320 in high-risk patients undergoing CT scans.

How does iopamidol-370 compare to iodixanol-320 in terms of contrast enhancement?

Iopamidol-370 provides significantly greater enhancement during the arterial phase and similar enhancement during the portal venous phase compared to iodixanol-320.

What are the key drivers of the iopamidol injection market growth?

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

Which region is expected to dominate the iopamidol injection market?

North America is expected to dominate the market due to the high prevalence of chronic diseases and well-established healthcare infrastructure.

Sources

1. Late-Breaking Clinical Trial Results Reveal No Statistically Significant Difference Between Iopamidol-370 and Iodixanol-320 in the Rate of Contrast-Induced Nephropathy (CIN) in High-Risk Patients Undergoing Computed Tomography (CT). Gale.
2. Strategic Vision for Iopamidol Injection Market Expansion. Data Insights Market.
3. A Comparison of the Efficacy and Safety of Iopamidol-370 and Iodixanol-320 in Contrast-Enhanced, Multidetector-Row Computed Tomography (CE-MDCT). PubMed.
4. EU Clinical Trials Register. Clinical Trials Register.
5. Global Iopamidol Injection Market Research Report 2024. Valuates Reports.