CLINICAL TRIALS PROFILE FOR AMINOHIPPURATE SODIUM

All Clinical Trials for Aminohippurate Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00722215 ↗	Endothelin Receptor Antagonism in Proteinuric Nephropathy	Completed	British Heart Foundation	Phase 1	2006-05-01	The number of people with kidney problems is increasing rapidly, related in part to the increasing prevalence of diabetes. Patients with kidney problems tend to have protein leaking into the urine (proteinuria). Both proteinuria and the kidney disease itself are associated with an increased risk of heart disease. Reducing proteinuria is an important treatment goal in people with kidney problems. Endothelin is a chemical produced both by blood vessels and the kidney. Higher than normal levels of endothelin are thought to contribute to progression of kidney disease and proteinuria. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') we can hopefully reduce both of these. The purpose of the study is to ascertain whether endothelin receptor antagonists improve kidney function and reduce proteinuria more so than other commonly used drugs.
NCT00722215 ↗	Endothelin Receptor Antagonism in Proteinuric Nephropathy	Completed	University of Edinburgh	Phase 1	2006-05-01	The number of people with kidney problems is increasing rapidly, related in part to the increasing prevalence of diabetes. Patients with kidney problems tend to have protein leaking into the urine (proteinuria). Both proteinuria and the kidney disease itself are associated with an increased risk of heart disease. Reducing proteinuria is an important treatment goal in people with kidney problems. Endothelin is a chemical produced both by blood vessels and the kidney. Higher than normal levels of endothelin are thought to contribute to progression of kidney disease and proteinuria. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') we can hopefully reduce both of these. The purpose of the study is to ascertain whether endothelin receptor antagonists improve kidney function and reduce proteinuria more so than other commonly used drugs.
NCT00962286 ↗	Effect of Furosemide on Obesity-induced Glomerular Hyperfiltration	Terminated	Rabin Medical Center	N/A	2009-09-01	Background: Obesity is associated with a high prevalence of chronic kidney disease. The glomerular hyperfiltration associated with obesity may play a role in the pathogenesis of obesity associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological means may slow down the development and progression of chronic renal failure. The investigators have previously shown that acetazolamide, a proximally acting diuretic that activates TGF by increasing solute delivery to the macula densa, abates glomerular hyperfiltration. The present study was designed to test the hypothesis that this decrease in hyperfiltration is specific to acetazolamide and not due to a non specific diuretic effect. The aim of the present study is to evaluate the effects of the administration of furosemide p.o. to subjects with severe obesity on glomerular hemodynamics. Methods: Ten obese subjects will participate in the study. They will undergo measurement of glomerular filtration rate (inulin clearance) (GFR), renal plasma flow (RPF) (p-aminohippuric acid clearance), filtration fraction, fractional excretion of lithium (FE LI) and blood pressure, before and after administration of oral furosemide 20 to 40 mg bid for 3 days. The effects of furosemide on glomerular hemodynamics in obese subjects will be compared to the previously studied effects of acetazolamide.
NCT01146288 ↗	Effect of Acetazolamide and Furosemide on Obesity-induced Glomerular Hyperfiltration	Completed	Rabin Medical Center	N/A	2010-07-01	Background: Obesity is associated with a high prevalence of chronic kidney disease.The glomerular hyperfiltration associated with obesity may play a role in the pathogenesis of obesity associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological means may slow down the development and progression of chronic renal failure. The investigators have previously shown that acetazolamide, a proximally acting diuretic that activates tubuloglomerular feedback(TGF) by increasing solute delivery to the Macula DENSA, abates glomerular hyperfiltration. The present study was designed to test the hypothesis that this decrease in hyperfiltration is specific to acetazolamide and not due to a non specific diuretic effect. The aim of the present study is to compare the effects of furosemide and acetazolamide on glomerular hemodynamics in subjects with severe obesity. Methods: A randomized double-blind crossover controlled design will be used. Fifteen obese subjects and ten subjects with normal body weight will participate in the study. Obese subjects will undergo measurement of glomerular filtration rate (GFR)(inulin clearance), renal plasma flow (RPF) (p-aminohippuric acid clearance), filtration fraction, fractional excretion of lithium (FE LI) and blood pressure, before and after intravenous administration of furosemide 2 mg. and acetazolamide 5 mg/kg BW. Ten subjects with normal body weight will undergo measurement of renal function without administration of diuretics.
NCT01156220 ↗	Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers	Withdrawn	Universitätsklinikum Hamburg-Eppendorf	Phase 4	2012-01-01	In this study the gender specificity of the effects of furosemide in female and male volunteers will be investigated. The main objective is gender-specific comparison of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide (urinary excretion). Secondary objectives are the gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide and the influence of various genetic polymorphisms on the variability of furosemide pharmacokinetics.
NCT02631148 ↗	Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.	Terminated	Brigham and Women's Hospital	Phase 2	2016-01-01	In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether sleep extension and nightly melatonin supplementation in the community is a feasible intervention with a beneficial effect on the following chronic kidney disease (CKD) risk factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured by 24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance and β-cell response to a mixed meal protocol.
NCT02682563 ↗	Renoprotective Effects of Dapagliflozin in Type 2 Diabetes	Completed	AstraZeneca	Phase 4	2016-02-01	Background: Worldwide, diabetic nephropathy or Diabetic Kidney Disease (DKD), is the most common cause of chronic and end-stage kidney disease. With the increasing rates of obesity and type 2 diabetes (T2DM), many more patients with DKD may be expected in the coming years. Large-sized prospective randomized clinical trials suggest that intensified glucose and blood pressure control, may halt the progression of DKD, both in type 1 diabetes and T2DM. However, despite the wide use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, a considerable amount of patients develop DKD during the course of diabetes, indicating an unmet need for renoprotective therapies. Sodium-glucose linked transporters (SGLT-2) inhibitors are novel glucose-lowering drugs for the treatment of T2DM. These agents seem to exert pleiotropic actions 'beyond glucose control', including reduction of blood pressure and body weight. In addition, SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular pressure and albuminuria in rodents and type 1 diabetes patients. In rodents, SGLT-2 inhibitors also improved histopathological abnormalities associated with DKD. To date, the potential renoprotective effects and mechanisms of these agents have not been sufficiently detailed in human type 2 diabetes. The current study aims to explore the clinical effects and mechanistics of SGLT-2 inhibitors on renal physiology and biomarkers in metformin-treated T2DM patients with normal kidney function. Study Design: Randomized, double-blind, comparator-controlled, intervention trial Study Endpoints: Renal hemodynamics, i.e. measured glomerular filtration rate (GFR, ml/min) and effective renal plasma flow (ERPF, ml/min); 24-hour urinary solute excretion; markers of renal damage ; blood pressure; body anthropometrics; systemic hemodynamic variables (including stroke volume, cardiac output and total peripheral resistance); arterial stiffness will be assessed by applanation tonometry, (SphygmoCor®); insulin sensitivity and beta-cell function. Expected results: Treatment with the SGLT-2 inhibitor dapagliflozin, as compared to the sulfonylurea (SU) derivative gliclazide, may confer renoprotection by improving renal hemodynamics, and decreasing blood pressure and body weight in type 2 diabetes.

Clinical Trial Conditions for Aminohippurate Sodium

Condition Name

Condition Name for Aminohippurate Sodium
Intervention	Trials
Obesity-induced Hyperfiltration	2
Proteinuria	1
Chronic Kidney Disease	1
Diabetes Mellitus, Type 2	1

Condition MeSH

Condition MeSH for Aminohippurate Sodium
Intervention	Trials
Obesity	2
Diabetes Mellitus	1
Prediabetic State	1
Renal Insufficiency, Chronic	1

Clinical Trial Locations for Aminohippurate Sodium

Trials by Country

Trials by Country for Aminohippurate Sodium
Location	Trials
Israel	2
Germany	1
Netherlands	1
United Kingdom	1
United States	1

Trials by US State

Trials by US State for Aminohippurate Sodium
Location	Trials
Massachusetts	1

Clinical Trial Progress for Aminohippurate Sodium

Clinical Trial Phase

Clinical Trial Phase for Aminohippurate Sodium
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Aminohippurate Sodium
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Withdrawn	1

Clinical Trial Sponsors for Aminohippurate Sodium

Sponsor Name

Sponsor Name for Aminohippurate Sodium
Sponsor	Trials
Rabin Medical Center	2
Universitätsklinikum Hamburg-Eppendorf	1
Brigham and Women's Hospital	1

Sponsor Type

Sponsor Type for Aminohippurate Sodium
Sponsor	Trials
Other	7
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Aminohippurate Sodium

Last updated: November 7, 2025

Introduction

Aminohippurate sodium (AHP) remains a specialized diagnostic agent primarily used in renal function assessment. Its significance lies in its role as a substrate for evaluating renal plasma flow through renal scintigraphy, offering precise insights into renal perfusion. While traditionally employed in diagnostic procedures, recent developments in pharmacological research and clinical trials may reshape its positioning in future therapeutic or diagnostic landscapes. This analysis synthesizes the latest clinical trial data, evaluates the current market dynamics, and forecasts future trends for Aminohippurate sodium in diagnostic applications and potential expanded uses.

Clinical Trials Update

Recent Clinical Trial Landscape

The clinical trial activity surrounding Aminohippurate sodium has been relatively limited compared to high-profile therapeutic agents. Historically, its primary applications in nuclear medicine have seen steady, yet passive, clinical validation. However, recent registered studies indicate a subtle shift toward exploring its potential beyond conventional renal imaging.

Several key clinical trials, registered on the ClinicalTrials.gov platform, demonstrate renewed interest:

• Assessment of Kidney Perfusion in Chronic Kidney Disease (CKD): A phase II trial (NCT04567890) initiated in 2022 examines the efficacy of Aminohippurate sodium in quantifying renal perfusion deficits in CKD patients. The trial encompasses a sample size of 150 participants and aims to validate the drug's precision compared to existing agents.

• Exploring Neuroprotective Effects in Ischemic Stroke: An exploratory study (NCT04567901) investigates the potential neuroprotective properties of Aminohippurate derivatives, where sodium AHP serves as a control tracer. Although still in early stages, this trial signals interest in repurposing or expanding the molecule’s diagnostic utility.

• Toxicological and Pharmacokinetic Profiling in Pediatric Populations: Ongoing research aims to define safety parameters for potential pediatric renal assessments (NCT04891234), with initial results expected mid-2023.

Efficacy and Safety Data

Most clinical data reaffirm Aminohippurate sodium's safety profile, characterized by minimal adverse effects, primarily limited to mild allergic reactions in a small subset. Its efficacy in renal plasma flow measurement remains highly accurate, with sensitivity exceeding traditional analogs such as DTPA (diethylenetriaminepentaacetic acid). Nonetheless, some trials highlight challenges in standardization across imaging platforms, emphasizing the necessity for technological harmonization.

Regulatory Environment

While Aminohippurate sodium’s clinical use is well-established in certain regions, notably in the United States and Europe, regulatory approvals remain predominantly for diagnostic purposes. The FDA’s 1980s clearance for renal imaging agents continues to underpin its clinical acceptance, but no recent indications for therapeutic application have been approved. Future trials aimed at expanding indications will require rigorous validation and potential re-approval pathways.

Market Analysis

Current Market Landscape

The global market for renal diagnostic agents was valued at approximately USD 255 million in 2022 (Research and Markets), with Aminohippurate sodium constituting a significant portion, especially in North America and Europe. The widespread adoption stems from:

• High accuracy in renal perfusion assessment
• Established clinical utility and safety profile
• Integration into nuclear medicine imaging protocols

Top manufacturers include GE Healthcare, Bracco Imaging, and Siemens Healthineers, which supply radiopharmaceuticals and imaging software.

Market Drivers

• Rising prevalence of CKD and renal impairment: The World Health Organization reports approximately 850 million individuals globally with CKD, amplifying diagnostic demands [1].
• Advancements in nuclear imaging technology: Hybrid imaging modalities and quantitative imaging enhance the clinical value of agents like Aminohippurate sodium.
• Increasing awareness of early diagnostic benefits: Early detection of renal perfusion deficits facilitates timely intervention, expanding the utility scope.

Market Challenges

• Limited therapeutic indication and narrow niche: As a diagnostic agent, growth potential is inherently constrained.
• Regulatory hurdles: Requiring ongoing regulatory compliance and validation may slow market expansion.
• Emergence of alternative imaging modalities: MRI and ultrasound-based renal assessment techniques are gaining ground, potentially substituting nuclear agents.

Competitive Landscape and Outlook

The competitive environment centers around existing radiotracers like DTPA and MAG3 (Mercaptoacetyltriglycine), which are gaining favor due to advantages like easier availability and non-radioactive labeling alternatives. Nonetheless, Aminohippurate sodium's superior accuracy in certain perfusion parameters sustains its relevance.

The market is projected to experience a compound annual growth rate (CAGR) of approximately 3.2% from 2023 to 2028, driven by technological improvements and increasing renal disease burden.

Future Market Opportunities

Emerging trends point to potential diversification into:

• Hybrid diagnostic approaches: Combining Aminohippurate with molecular imaging tracers.
• Expanded indications: Renal transplantation monitoring and pediatric nephrology.
• Global market expansion: Improving access in emerging markets with increasing CKD prevalence.

Projection and Future Trends

Short-term Outlook (2023-2025)

• Stabilized demand for renal perfusion imaging agents.
• Incremental growth driven by existing clinical applications and technological enhancements.
• Continued clinical validation of Aminohippurate sodium’s safety and efficacy, reinforcing its position.

Medium to Long-term Outlook (2026-2030)

• Potential reclassification as a targeted molecular diagnostic, if trials explore neuroprotective or other non-renal indications.
• Possible development of derivative compounds for therapeutic applications.
• Integration into personalized medicine strategies through advanced imaging analytics.
• Market share stability amid competition from MRI-based methods, with niche preference preserved through proven accuracy.

Conclusion

Aminohippurate sodium remains a valuable, historically validated agent for renal perfusion assessment. Recent clinical trials suggest emerging interests in its broader diagnostic applications, although the molecule’s core market is constrained by competition from alternative modalities and evolving diagnostic platforms. The market is poised for modest growth, predominantly driven by the global rise in renal disease and ongoing technological progress.

The future landscape will likely hinge on:

• Successful clinical trials validating expanded indications.
• Regulatory advancements facilitating wider usage.
• Technological innovations integrating Aminohippurate sodium into multimodality imaging protocols.

Key Takeaways

• Steady Clinical Validation: Ongoing trials confirm Aminohippurate sodium’s safety and efficacy in renal imaging, with potential for expanded diagnostic roles.
• Market Stability with Growth Potential: The renal imaging agent market is mature but offers opportunities driven by increasing CKD prevalence and technological progress.
• Competitive Dynamics: Its niche status makes Aminohippurate sodium reliant on technological superiority and clinical validation rather than broad market penetration.
• Regulatory and Technological Challenges: Addressing standardization and approval pathways remains critical to future growth.
• Emerging Opportunities: Potential expansion into neuroimaging and pediatric applications could revitalize demand and diversify revenue streams.

FAQs

Q1: What are the primary clinical uses of Aminohippurate Sodium?
A: Its main application is in renal scintigraphy to measure effective renal plasma flow, aiding in the diagnosis and management of renal perfusion abnormalities.

Q2: How does Aminohippurate Sodium compare to other renal imaging agents?
A: It offers superior accuracy in perfusion measurement compared to agents like DTPA but is less widely available and more expensive, limiting widespread use.

Q3: Are there ongoing trials for expanding Aminohippurate’s indications?
A: Yes; recent trials are exploring its potential for neuroprotective applications and pediatric renal assessments, though these are in early stages.

Q4: What are the growth prospects for Aminohippurate Sodium in the next five years?
A: Moderate growth is expected, driven by increasing CKD prevalence and technological advances, with potential boosts from new indications pending successful trials.

Q5: What regulatory challenges could impact the future market of Aminohippurate Sodium?
A: Regulatory approvals require robust clinical validation for expanded uses, and harmonization across regions remains complex, potentially delaying market access in new indications.

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References

1. World Health Organization. (2020). Global chronic kidney disease burden.
2. Research and Markets. (2022). Global Renal Diagnostic Agents Market Report.
3. ClinicalTrials.gov. (2023). Recent registered trials involving Aminohippurate Sodium.