CLINICAL TRIALS PROFILE FOR FENOLDOPAM MESYLATE

All Clinical Trials for FENOLDOPAM MESYLATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01690832 ↗	Fenoldopam for Prevention of Acute Kidney Injury	Unknown status	University of Roma La Sapienza	Phase 4	2012-09-01	Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography. The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial. Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies. Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy. The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.
NCT01073189 ↗	Intra-Renal Therapy of Diuretic Unresponsive Acute Kidney Injury	Withdrawn	Southeast Renal Research Institute	Phase 4	2010-04-01	Randomized prospective trial of patients with diuretic unresponsive acute kidney injury where patients will receive standard supportive therapy with diuretics versus intra-renal delivery of the vasodilator fenoldopam mesylate. Patients with rising creatinine who fail to respond to bolus diuretics will be treated with a prolonged course of diuretics or undergo placement of a catheter within the renal arteries that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a high dose vasodilator may reverse the decline of renal function in patients with severe acute kidney injury.
NCT00286403 ↗	Vasodilators and Anti-Oxidant Therapy in Early ATN	Withdrawn	Dialysis Clinic, Inc.	Phase 2/Phase 3	2008-08-01	Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. The investigators hypothesize that administration of fenoldopam mesylate (a drug that increases blood flow to the kidney) to patients early in the course of their disease could reduce progression to dialysis-dependent acute renal failure. The investigators also hypothesize that restoring blood flow could induce additional injury to the kidney through the release of reactive oxygen species. Therefore, patients in this protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. The investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients with early post-operative acute renal failure.
NCT00286403 ↗	Vasodilators and Anti-Oxidant Therapy in Early ATN	Withdrawn	Southeast Renal Research Institute	Phase 2/Phase 3	2008-08-01	Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. The investigators hypothesize that administration of fenoldopam mesylate (a drug that increases blood flow to the kidney) to patients early in the course of their disease could reduce progression to dialysis-dependent acute renal failure. The investigators also hypothesize that restoring blood flow could induce additional injury to the kidney through the release of reactive oxygen species. Therefore, patients in this protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. The investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients with early post-operative acute renal failure.

Clinical Trial Conditions for FENOLDOPAM MESYLATE

Condition Name

Condition Name for FENOLDOPAM MESYLATE
Intervention	Trials
Kidney Failures, Acute	1
Acute Renal Failure	1
Coronary Artery Disease	1

Condition MeSH

Condition MeSH for FENOLDOPAM MESYLATE
Intervention	Trials
Acute Kidney Injury	3
Renal Insufficiency	2
Myocardial Ischemia	1
Coronary Disease	1

Clinical Trial Locations for FENOLDOPAM MESYLATE

Trials by Country

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−

Trials by Country for FENOLDOPAM MESYLATE
Location	Trials
United States	3
Italy	1

Trials by US State

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−

Trials by US State for FENOLDOPAM MESYLATE
Location	Trials
Tennessee	2
District of Columbia	1

Clinical Trial Progress for FENOLDOPAM MESYLATE

Clinical Trial Phase

Clinical Trial Phase for FENOLDOPAM MESYLATE
Clinical Trial Phase	Trials
Phase 4	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for FENOLDOPAM MESYLATE
Clinical Trial Phase	Trials
Withdrawn	2
Unknown status	1

Clinical Trial Sponsors for FENOLDOPAM MESYLATE

Sponsor Name

Sponsor Name for FENOLDOPAM MESYLATE
Sponsor	Trials
Southeast Renal Research Institute	2
Dialysis Clinic, Inc.	1
University of Roma La Sapienza	1

Sponsor Type

Sponsor Type for FENOLDOPAM MESYLATE
Sponsor	Trials
Other	3
Industry	1

Fenoldopam Mesylate: Clinical Trials, Market Analysis, and Projections

Introduction

Fenoldopam mesylate is a dopamine-1 receptor agonist used primarily for the treatment of severe or malignant hypertension and has been explored for its potential in preventing renal complications. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Contrast-Induced Nephropathy

One of the significant clinical trials involving fenoldopam mesylate is the CONTRAST trial, which aimed to evaluate its efficacy in preventing contrast-induced nephropathy in patients undergoing invasive cardiovascular procedures. This prospective, placebo-controlled, double-blind, multicenter randomized trial involved 315 patients with creatinine clearance less than 60 mL/min. Patients were randomized to receive either fenoldopam mesylate or a placebo.

• Results: The trial found that fenoldopam mesylate did not prevent further renal function deterioration after contrast administration. The primary endpoint of contrast-induced nephropathy occurred in 33.6% of patients in the fenoldopam group versus 30.1% in the placebo group, with no significant differences in 30-day rates of death, dialysis, or rehospitalization[1].

Acute Tubular Necrosis

Another clinical trial focused on the use of fenoldopam mesylate in early acute tubular necrosis (ATN). This prospective, randomized, double-blind, placebo-controlled trial involved 155 patients with early ATN. Patients received either fenoldopam or a placebo for 72 hours.

• Results: The trial showed that fenoldopam did not reduce the incidence of death or dialysis therapy in intensive care unit patients with early ATN. However, secondary analyses suggested that fenoldopam might reduce the primary endpoint in patients without diabetes and in postoperative cardiothoracic surgery patients[4].

Mechanism of Action

Fenoldopam mesylate acts as a specific agonist of the dopamine-1 receptor, leading to systemic, peripheral, and renal arterial vasodilatation. This mechanism is thought to increase renal blood flow and potentially mitigate renal damage in certain conditions[1].

Market Analysis

Current Market Size

The global fenoldopam mesylate injection market has seen significant growth in recent years. As of 2023, the market was valued at approximately $280 million[5].

Market Segmentation

The market is segmented by type (1ml and 2ml vials) and application (hospitals, clinics, and other settings). Geographically, the market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2][5].

Market Projections

Projections indicate a continued growth in the market, with the global fenoldopam mesylate injection market expected to reach $388.2 million by 2030, growing at a CAGR of 5.3% during the forecast period from 2024 to 2030[5].

Drivers and Restraints

The market growth is driven by factors such as the increasing incidence of hypertension and the need for effective treatments. However, the lack of conclusive evidence on the efficacy of fenoldopam mesylate in preventing renal complications, as seen in clinical trials, may act as a restraint[1][4][5].

Competitive Landscape

The competitive landscape of the fenoldopam mesylate injection market involves several manufacturers. The market report provides a detailed analysis of these manufacturers, including their competitive strategies, pricing, sales, and revenue market share. The report also covers recent developments, mergers, and acquisitions within the industry[5].

Regional Analysis

The market is analyzed at both regional and country levels. North America, Europe, and Asia-Pacific are among the key regions, with each having significant market shares. The report provides insights into the market development, future prospects, and market size of each country within these regions[5].

Conclusion

Fenoldopam mesylate, while showing promise in theoretical mechanisms, has not demonstrated significant efficacy in clinical trials for preventing renal complications such as contrast-induced nephropathy and acute tubular necrosis. However, the drug remains a valuable treatment option for severe or malignant hypertension. The market for fenoldopam mesylate injections is expected to grow, driven by the increasing need for hypertension treatments, despite the mixed results from clinical trials.

Key Takeaways

• Clinical Trials: Fenoldopam mesylate has not shown significant efficacy in preventing contrast-induced nephropathy or acute tubular necrosis.
• Market Size: The global market was valued at $280 million in 2023 and is projected to reach $388.2 million by 2030.
• Market Growth: The market is expected to grow at a CAGR of 5.3% from 2024 to 2030.
• Segmentation: The market is segmented by type, application, and geographical regions.
• Drivers and Restraints: Market growth is driven by the need for hypertension treatments, but restrained by mixed clinical trial results.

FAQs

What is the primary use of fenoldopam mesylate?

Fenoldopam mesylate is primarily used to treat severe or malignant hypertension.

Did fenoldopam mesylate prevent contrast-induced nephropathy in clinical trials?

No, fenoldopam mesylate did not prevent contrast-induced nephropathy in the CONTRAST trial[1].

What are the projected market values for fenoldopam mesylate injections?

The market is expected to grow from $280 million in 2023 to $388.2 million by 2030[5].

Which regions are key in the fenoldopam mesylate injection market?

North America, Europe, and Asia-Pacific are among the key regions in the market[5].

What is the mechanism of action of fenoldopam mesylate?

Fenoldopam mesylate acts as a specific agonist of the dopamine-1 receptor, leading to systemic, peripheral, and renal arterial vasodilatation[1].

Sources

1. JAMA Network: Fenoldopam Mesylate for the Prevention of Contrast-Induced Nephropathy.
2. Market Research Intellect: Global Fenoldopam Mesylate Injection Market Size, Scope And Forecast.
3. Wiley Online Library: An update and appraisal of the cilomilast Phase III clinical development programme.
4. PubMed: Fenoldopam mesylate in early acute tubular necrosis.
5. QY Research: Global Fenoldopam Mesylate Injection Market Research Report 2024.