Oral Iohexol in the Management of Chylous Ascites After Retroperitoneal or Extended Lymphadenectomy for Abdominal or Pelvic Malignant Tumor: an Innovative and Convenient Treatment

The goal of this clinical trial is to assess the effectiveness of oral iohexol in the treatment of postoperative chylous ascites. It will also learn about the safety of oral iohexol. The main questions it aims to answer are:
* Confirm the potential of oral iohexol as an innovative therapeutic regimen.
* Confirm its ability to improve clinical outcomes for patients.

Start Date15 Feb 2025

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

NCT06709521

/ RecruitingPhase 4IIT

Optimization of Beta-lactam Dosing in Critically Ill Patients With Suspected or Documented Antimicrobial Resistant Gram-Negative Infections With Cystatin-C (OPTIMIZE-GNI)

The purpose of this study is to evaluate the abilities of Cystatin C (CysC) and CysC-based estimated Glomerular Filtration Rate (eGFR) equations to characterize the pharmacokinetics (PK) profiles of meropenem and cefepime relative to Serum Creatinine (SCR), Serum Creatinine based Equation (SCRE)and iohexol at the population and individual levels in critically ill adult patients with suspected or documented AMR Gram-negative infections. We hypothesize that CysC and CysC-based eGFR equations will characterize the PK profiles of meropenem and cefepime at the population and individual levels with greater accuracy and precision than SCR and SCREs. Iohexol will be administered to patients enrolled in the study and serve as the reference indicator of measured Glomerular Filtration Rate (mGFR), which is the gold standard assessment of kidney function. We hypothesize that the predictive performances of CysC and CysC-based eGFR equations in estimating the PK profiles of meropenem and cefepime at the population and individual levels will be comparable to iohexol. The information obtained in this study will be used to develop PK/pharmacodynamics (PD) optimized meropenem and cefepime dosing schemes based on the renal function biomarker population PK (PopPK) model with the best predictive performance for clinical use in the treatment of critically ill adult patients with suspected or documented AMR Gram-negative infections and varying degrees of renal function. The primary objective of this study is to compare the abilities of renal function biomarkers (CysC, CysC-based eGFR equations, SCR, SCREs) relative to iohexol to characterize the PK profiles of meropenem and cefepime in critically ill adult patients with suspected or documented AMR Gram-negative infections.

Start Date11 Feb 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT05136963

/ Not yet recruitingPhase 1IIT

Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.

In kidney transplantation, donor selection is based in part on the assessment of the functional capacity of the kidneys. For this purpose, it is recommended to measure the glomerular filtration rate (GFR) by a reference technique. To estimate GFR, several approaches are possible depending on the type of measurement (urinary or plasma) and the marker (exogenous or endogenous) used. Among these methods, the measurement of inulin clearance has long been considered the reference method. The occurrence of anaphylactic reactions led to its withdrawal from the market. Iohexol, an iodinated contrast agent, has characteristics similar to inulin. It is eliminated by glomerular filtration and its biological determination is simple.
Nevertheless, the techniques currently used to calculate plasma clearance of Iohexol have been imperfectly validated and are not always easy to implement in practice. the investigators propose to develop a Bayesian estimator for estimating Iohexol clearance applied to a population of healthy subjects, representative of potential kidney donors.

Start Date01 Jun 2024

Sponsor / Collaborator

Centre Hospitalier Universitaire de Saint-Etienne

100 Clinical Results associated with Iohexol

100 Translational Medicine associated with Iohexol

100 Patents (Medical) associated with Iohexol

3,376

Literatures (Medical) associated with Iohexol

01 Jun 2025·SEPARATION AND PURIFICATION TECHNOLOGY

Transition metal induced interfacial d-p orbital hybridization boosting biochar for efficient fenton-like decontamination

Author: She, Tiantian ; Ji, Qiuyi ; Zhang, Limin ; Wang, Hengle ; Yang, Shaogui ; Wang, Yunheng ; Wang, Renjie ; Xu, Zhe ; He, Huan

Transition metals (TMs) are widely employed to improve poor intrinsic activity of biochar for peroxymonosulfate (PMS) activation towards water purificationHowever, the mechanistic effects of TMs on carbon substrates requires further understanding.Herein, we constructed TM-modified C-Ni and C-Ni-Co catalysts via simple pyrolysis of rice husk precursor, optimizing carbonaceous morphol. and electronic structures.The Co-Ni-Co (0.013 min^-1) exhibited over 10 times higher performance than pristine biochar for iohexol (IOH) removal.Systemic spectroscopic and electrochem. measurements indicate that embedded Ni increases graphitization degree facilitating IOH adsorption by π-π conjugated attraction.And, the anchored Co enhances work function promoting electron extraction for selective generation of ¹O₂.The interfacial d-p orbital hybridization increases the acidic degree on biochar for PMS adsorption, accelerating electron exchange for PMS activation.Our work attempts to study the complex interaction between carbon and metal sites by orbital hybridization to design efficient PMS activators for Fenton-like decontamination.

01 Jun 2025·SEPARATION AND PURIFICATION TECHNOLOGY

Improving peroxymonosulfate activation via surface-constructed oxygen vacancies on Co0.2FeOx for durable water decontamination

Author: Chen, Zhonglin ; Yan, Pengwei ; Zhang, Ziliang ; Li, Yabin ; Ma, Fang ; Shen, Jimin ; Wu, Wenyu ; Sun, Lianpeng ; Kang, Jing ; Wang, Binyuan ; Cheng, Yizhen

Activating peroxymonosulfate (PMS) to generate sulfate radicals (SO.-4) is an effective method for water purificationAn efficient, low-cost, and easily synthesized catalyst ensures decontamination performance and practical application feasibility.In this work, oxygen vacancy-enriched magnetic Co0.2FeOx was synthesized by isomorphous substitution of Fe3+ with Co2+ in α-FeOOH and employed to activate PMS to degrade iohexol, an iodinated X-ray contrast media widely detected in water.Co0.2FeOx exhibited higher performance than previously reported transition metal oxides.Iohexol could be effectively degraded in the Co0.2FeOx-catalyzed system from pH 3.5 to 10.5 compared to PMS oxidation alone.In situ tests in D2O and H2O using ATR-FTIR spectra inferred that the oxygen vacancies on the Co0.2FeOx surface could facilitate the formation of surface hydroxyl groups, which could complex HSO-5 to form Me-(OH)-OSO-3.Electron transfer in the inner complex via the redox of Co(II)/Co(III) and Fe(III)/Fe(II) caused the breakage of the O-O bonds, thus promoting free radical generation.ESR spectra identified SO.-4 and .OH as the predominant active species.This study suggests new ideas for the synthesis of efficient catalysts and elucidates new insights into the interfacial mechanism of PMS activation.

04 Mar 2025·Bioanalysis

Improved real-world UHPLC-MS/MS iohexol analysis; thawed samples, improved calibration curve, and additional matrices

Article

Author: Junier, Lenneke A T ; Touw, Daan ; Wessels, A Mireille A ; Stevens, Jasper

BACKGROUND:

Plasma clearance of iohexol is used to measure glomerular filtration rate, for which a UHPLC-MS/MS analytical method was previously developed. In real-world conditions, samples may be thawed on arrival and sampled in unvalidated matrices, prompting the need for an improved validation. We aim to improve the method for iohexol determination in plasma with enhanced stability testing, optimized calibration curves, and partial validation in additional matrices.

METHODS:

Stability testing was conducted up to 9 weeks at room temperature, 4°C, 37°C, and at 37°C with daily two-hour exposure to 55°C. Quintuplicate QC samples were analyzed on 3 days, comparing results from eight-point and two-point calibration curves. Matrix comparison was performed on quintuplicate QC samples in serum, heparin plasma, urine, EDTA whole blood, and heparin whole blood.

RESULTS:

The method improvements were all compliant with the requirements for bioanalytical methods issued by the US FDA and European Medicines Agency.

CONCLUSION:

Human EDTA plasma samples can be stored up to 9 weeks at room temperature, 4°C, 37°C, and 37°C with 55°C daily temperature spikes. The samples can be analyzed using a two-point calibration curve and are partial validated for serum-, heparin plasma-, urine-, EDTA whole blood-, and lithium whole blood iohexol samples.

News (Medical) associated with Iohexol

05 Mar 2025

·endpts.com

UK biotech unveils early data for antibiotic in chronic back pain

Persica Pharmaceuticals said it has promising Phase 1b results that support its approach of using a two-dose antibiotic to treat a subset of patients with chronic back pain. Chronic low back pain in some people seems to be caused by so-called indolent infections in the lumbar disc, the London-based drugmaker said. These infections don’t behave like typical infections because they are persistent and there are none of the usual symptoms like fever, CEO Steve Ruston told Endpoints News in an interview. Bacteria in the disc can cause inflammation and bone degradation over time, which then triggers pain, Ruston added. The infection leads to changes — known as Modic changes — in the bone marrow that can be detected on an MRI scan. There are four different types of Modic changes, with type 1 signifying bone marrow swelling and inflammation. In a Phase 1b study of people with chronic low back pain and Modic type 1 changes, Persica’s antibiotic, dubbed PP353, achieved a 50% reduction in pain scores from baseline. This worked out to a roughly 30% reduction in pain scores compared with placebo, according to a Wednesday press release. The trial enrolled 44 patients who hadn’t benefited from non-surgical standard of care, such as physiotherapy and painkillers. The patients given the antibiotic experienced an average 63% reduction in their disability scores. Their pain and disability scores were still improving at 12 months, suggesting the treatment’s effect improves over time, the company said. PP353 contains a combination of the antibiotic linezolid, contrast agent iohexol and a thermosensitive gel. It is injected into the lumbar disc in two doses given four days apart in an effort to eliminate the infection. Persica’s antibiotic approach is markedly different from other non-opioid drugs in clinical development for acute or chronic pain. Many other companies are advancing voltage-gated sodium channel blockers. Vertex’s Journavx became the first drug from this class to secure FDA approval for acute pain back in January. Other targets being explored for pain include AAK1 and NMDA. Persica is preparing for regulatory discussions to advance PP353 into registrational development. While the asset is unique, its components have been used in other drug products, which makes a stronger case for faster development, Ruston said. Chronic low back pain patients with Modic type 1 changes are a “common” subgroup, with more than two million of them in the US alone, according to Persica. Besides non-surgical options, the only other treatment is nerve ablation surgery, which doesn’t address the root cause of the condition.

Clinical ResultPhase 1Drug Approval

25 Feb 2025

·www.prnewswire.com

MediBeacon® Transdermal GFR System receives device approval in China

Peer-reviewed articles on MediBeacon technology published Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal or impaired renal function. The Clinical Kidney Journal in February published MediBeacon study results on measured GFR (mGFR) using relmapirazin versus estimated GFR (eGFR) for the purpose of classifying patient Chronic Kidney Disease (CKD) stages. MediBeacon TGFR study results have been posted online in the February ahead of print section in the Journal of the American Society of Nephrology (JASN). ST. LOUIS, Feb. 25, 2025 /PRNewswire/ -- MediBeacon Inc. today announced the National Medical Products Administration (NMPA) in China has approved the MediBeacon® TGFR Monitor and TGFR Sensor for the assessment of kidney function in patients with normal or impaired renal function. Lumitrace® (relmapirazin) injection, categorized as a drug in China, is under review and is targeted for approval in late 2025. The transdermal GFR technology includes Lumitrace (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together with the TGFR Monitor and TGFR Sensor allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. In 2021, the NMPA granted the TGFR Innovative Medical Device Designation. Only 10% of applications are granted this designation. Benefits of this registration route including early product promotion are considerable. In February, the Clinical Kidney Journal published MediBeacon data in an article on Chronic Kidney Disease (CKD) stage misclassification via estimated GFR (eGFR) compared to measured GFR (mGFR) using relmapirazin. In a stable CKD population, more than one-third of the subjects had an actual mGFR (relmapirazin) that differed by at least one CKD stage from their estimated GFR (eGFR).1 Relmapirazin is indicated for use with the TGFR. "The Clinical Kidney Journal study raises serious concerns about how chronic kidney disease is diagnosed today," said Dr. Ira Kurtz, Chief of the Division of Nephrology at UCLA Medical Center. "Researchers found that current eGFR methods misclassified 35% of patients, leading to potentially incorrect treatments and delayed interventions." In the February ahead of print section in the Journal of the American Society of Nephrology (JASN), MediBeacon clinical study data from the use of transdermal detection of relmapirazin in patients with normal to impaired kidney function across a range of skin color types was posted online.2 JASN publishes high-impact research to advance the understanding and treatment of kidney diseases.3 In addition to his leadership role at UCLA Medical Center, Dr. Kurtz is active in the development of an artificial kidney and artificial intelligence in the training and practice of nephrology. Dr. Kurtz commented that: "The study in the Journal of the American Society of Nephrology introduces a wearable, transdermal device that assesses GFR without the need for blood samples. The fluorescence-based test, developed by MediBeacon, demonstrated an exceptional correlation (r² = 0.90) with plasma mGFR across all skin types, paving the way for more equitable and accurate kidney function assessment. These two new studies have reshaped the landscape of kidney disease diagnostics, offering both a cutting-edge innovation and a stark warning about current practices. The findings underscore the urgent need for improved kidney function assessment tools, with non-invasive, point of care GFR measurement emerging as a game-changing solution." "Awareness of kidney disease is relatively low despite the fact that it is the 7th leading risk factor for mortality worldwide.4 MediBeacon is pleased to have the opportunity to aid in the assessment of kidney function in China," said Steve Hanley CEO of MediBeacon. "NMPA approval is the culmination of a rigorous device application process that required close collaboration of the MediBeacon and Huadong Medicine teams. We look forward to the next phase of our partnership with Huadong Medicine and eagerly anticipate Lumitrace approval in China later this year." The TGFR, which includes Lumitrace (relmapirazin), was approved on January 17th by the U.S. Food and Drug Administration (FDA). MediBeacon continues development of future TGFR products including a next-generation TGFR Sensor with updated software and algorithms. About MediBeacon Inc. MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon's use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 55 granted U.S. patents and over 215 granted patents worldwide that provide extensive coverage of the MediBeacon ® TGFR, including Lumitrace ® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR is approved for human use. Potential technology applications in gastroenterology, ophthalmology and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: . About Lumitrace® (relmapirazin) injection Relmapirazin is a non-radioactive, non-iodinated pyrazine-based compound, which has been engineered to be inert, highly fluorescent, and have the clearance properties of a GFR tracer agent in the body. The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. In a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International by Dorshow et al.5 About MediBeacon® Transdermal GFR System (TGFR) The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin), which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient's bedside or in the outpatient setting. IMPORTANT SAFETY INFORMATION FOR TGFR (U.S. FDA) Indication for Use: The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function. The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, patients on dialysis, or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI). The MediBeacon® TGFR Sensor and exogenous tracer agent, Lumitrace® injection, are single use and are only used with the MediBeacon® TGFR. The MediBeacon® TGFR Sensor is a single use device intended to attach to the patient's skin and excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon® TGFR Monitor. Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment. Contraindications: There are no known contraindications. Warnings and Precautions: See ifu.medibeacon.com for full instructions, warnings, and cautions. In clinical studies no serious or severe adverse events have been observed. Lumitrace® injection has light absorbance at 266nm and 435nm, and broad fluorescent emission at ~560nm when excited at ~440nm. Any drug activated at these wavelengths should not be used in conjunction with Lumitrace. Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally-impaired patients). The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing. Bolus infusions may impact the GFR assessment temporarily while the vasculature-tissue equilibrium is re-established. During a TGFR session, the patient should be as still as possible, especially during the "Establishing Baseline" stage. The current system is designed to compensate for light activity such as reading or eating after the Baseline stage. 1 CKD stage misclassification between estimated GFR and measured GFR in a clinical study of chronic kidney patients, Clinical Kidney Journal, Dorshow, Richard B. et al., 2025 Jan 9;18(2):sfaf006. DOI: 10.1093/ckj/sfaf006 2 Glomerular Filtration Rate Measurement Utilizing Transdermal Detection Methodology, Journal of the American Society of Nephrology (JASN), Dorshow, Richard B. et al., February 7, 2025, DOI: 10.1681/ASN.0000000639 3 4 Chronic kidney disease and the global public health agenda: an international consensus, Nature Reviews Nephrology, 20, 473-485 (2024), doi.org/10.1038/s41581-024-00820-6 5 Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012 SOURCE MediBeacon WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2

17 Jan 2025

·www.prnewswire.com

MediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function

Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal or impaired renal function. The transdermal GFR (tGFR) methodology has been designed to be effective across the adult population without input of age, weight, sex, gender, race, or ethnicity. More than 800 million people have Chronic Kidney Disease (CKD), one of the world's leading causes of mortality worldwide, with associated deaths increasing over the past two decades.1 ST. LOUIS, Jan. 17, 2025 /PRNewswire/ -- MediBeacon Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the MediBeacon® TGFR for the assessment of kidney function in patients with normal or impaired renal function. The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient's bedside or in the outpatient setting. The TGFR is validated for use in the assessment of Glomerular Filtration Rate (GFR) in patients with stable kidney function at the point of care. The TGFR utilizes an intravenous Lumitrace injection but does not require blood draws or urine analysis, unlike current methodologies requiring multiple blood draws or urine samples. In addition, current clinical practice measured GFR (mGFR) assessment requires sophisticated clinical laboratory analysis away from the patient's point of care. "The development of a system such as the TGFR that assesses a patient's kidney function without the need to use estimating equations is an important milestone for the nephrology community," said Dr. Mitchell Rosner, chair of the Department of Medicine at University of Virginia and a highly regarded expert who has authored numerous articles on the challenges of assessing kidney function. "We are excited to explore applications of the transdermal GFR methodology in patients where current clinical practice is understood to be suboptimal." Dr. Pierre Galichon, an active kidney researcher at the Sorbonne Université and an attending physician in kidney transplantation at Pitié-Salpêtrière Hospital in Paris, said: "It has long been a challenge to understand kidney function in the context of its interaction with other vital organs, such as the heart and lungs. My experience with MediBeacon products in preclinical use, as relayed in Scientific Reports,2 has been exciting, and I look forward to evaluating how transdermal GFR can be applied in clinical practice." "The approval of the TGFR by the FDA demonstrates our proprietary system can provide an effective option for assessing kidney function," said Steve Hanley, CEO of MediBeacon. "According to the National Kidney Foundation, CKD causes more deaths each year than breast cancer or prostate cancer. It is the under-recognized public health crisis.3 The potential applications for the TGFR are numerous, and we look forward to exploring them with clinicians both in the hospital and outpatient settings." The timing of FDA approval aligns well with the Q4 2024 publication by MediBeacon's Chief Scientific Officer, Dr. Richard Dorshow, et al. in Kidney International4 with data that supports the utility of MediBeacon's patented agent Lumitrace®. The TGFR met its primary efficacy endpoint as per agreement with the FDA by demonstrating a P30 value of 94% while recruiting patients with a range of GFR values and skin tones. P30 is defined as the percentage of GFR estimation falling within +/- 30% of measured GFR (mGFR) values. In clinical studies no serious or severe adverse events have been observed. For more information, including the FDA Summary of Safety and Effectiveness Data, please refer to . About MediBeacon Inc. MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon's use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 55 granted U.S. patents and over 215 granted patents worldwide that provide extensive coverage of the MediBeacon ® TGFR, including Lumitrace ® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR is approved for human use. Potential technology applications in gastroenterology, ophthalmology and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: . About Lumitrace® (relmapirazin) injection Relmapirazin is a non-radioactive, non-iodinated pyrazine-based compound, which has been engineered to be inert, highly fluorescent, and have the clearance properties of a GFR tracer agent in the body. The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. In a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International by Dorshow et al. IMPORTANT SAFETY INFORMATION FOR TGFR Indication for Use: The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function. The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, patients on dialysis, or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI). The MediBeacon® TGFR Sensor and exogenous tracer agent, Lumitrace® injection, are single use and are only used with the MediBeacon® TGFR. The MediBeacon® TGFR Sensor is a single use device intended to attach to the patient's skin and excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon® TGFR Monitor. Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment. Contraindications: There are no known contraindications. Warnings and Precautions: See ifu.medibeacon.com for full instructions, warnings, and cautions. In clinical studies no serious or severe adverse events have been observed. Lumitrace® injection has light absorbance at 266nm and 435nm, and broad fluorescent emission at ~560nm when excited at ~440nm. Any drug activated at these wavelengths should not be used in conjunction with Lumitrace. Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally-impaired patients). The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing. Bolus infusions may impact the GFR assessment temporarily while the vasculature-tissue equilibrium is re-established. During a TGFR session, the patient should be as still as possible, especially during the "Establishing Baseline" stage. The current system is designed to compensate for light activity such as reading or eating after the Baseline stage. 1 Epidemiology of chronic kidney disease: an update 2022, Kidney International Supplement, 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003., Csaba P Kovesdy 2 Pulmonary hypertension without heart failure causes cardiorenal syndrome in a porcine model, Scientific Reports (2023) 13:9130, Orieux et al, doi.org/10.1038/s41598-023-36124-1 3 National Kidney Foundation, Fast Facts (2024 Update), Updated as of 8/6/2024 4 Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012 SOURCE MediBeacon WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2

100 Deals associated with Iohexol

External Link

KEGG	Wiki	ATC	Drug Bank
D01817	Iohexol	V08AB02	DB01362

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neoplasms	US	GE Healthcare, Inc.	24 Oct 1995
Contrast agents	US	GE Healthcare, Inc.	26 Dec 1985

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Kidney Injury	Phase 2	-	Ligand Pharmaceuticals, Inc.	01 Mar 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACAAI2024	Not Applicable	Acute Generalized Exanthematous Pustulosis	-	Iohexol	fzdclgslrh(htbibxuggz) = She developed a morbilliform rash after 3 days that progressed to pink edematous plaques with pinpoint pustules on day 6 konamqzrlp (blomhauykc ) View more	-	24 Oct 2024
NCT03618420 (CASPER, CTgov)	Phase 1/2	Diabetes Mellitus, Type 1 \| Diabetic Nephropathies	50	Iohexol Inj 300 mg/mL+Aminohippurate Sodium Inj 20%	sougaksccm(pzoekqjzdd) = apqbyuecpf dulqqpgbxe (ixrkthkfol, wkrqacpxpj - cdskviijdr) View more	-	31 Aug 2021
ISN WCN2021	Not Applicable	-	208	iohexol (CKD-EPIcr)	unezhdkici(xliizrlotp) = lknrkvotqy xknxhrjgfv (qgxbhscbmu ) View more	-	01 Apr 2021
ISN WCN2021	Not Applicable	-	208	iohexol (CKD-EPIcys)	unezhdkici(xliizrlotp) = jomjtebrfs xknxhrjgfv (qgxbhscbmu ) View more	-	01 Apr 2021
ASN2020	Not Applicable	-	-	HK-2 cells treated with iohexol for 6hrs	cssvgetjab(rpvrizybxh) = yewhmlnmsx yrdzstlxxb (yvhtssfpey ) View more	-	19 Oct 2020
ASN2020	Not Applicable	-	-	HK-2 cells treated with iohexol for 12hrs	cssvgetjab(rpvrizybxh) = mvyukncecq yrdzstlxxb (yvhtssfpey ) View more	-	19 Oct 2020
NCT02246998 (CTgov)	Phase 4	HIV Infections	72	STB+iohexol (STB + Iohexol)	cqtfbnwqiq(tlebndkrsf) = ucuglqhfop mmfrrhtbwe (zlgtotqtmk, wpeunhzyrp - xhcudtcovy) View more	-	03 Jan 2018
NCT02246998 (CTgov)	Phase 4	HIV Infections	72	ATV+iohexol+TVD+RTV (TVD + ATV/r + Iohexol)	cqtfbnwqiq(tlebndkrsf) = krxjqrovnu mmfrrhtbwe (zlgtotqtmk, fzebyobrpg - lqgguwmtkm) View more	-	03 Jan 2018
SP327 (ERA2017)	Not Applicable	Cystic Fibrosis aminoglycoside \| diabetes mellitus	21	Inuline clearance	gltbfzqczl(anzlxeomhi) = gayafhnblp knemnembqs (egkhsouzzs )	Positive	26 May 2017
ASN2016	Not Applicable	-	-	Iohexol (Single Sample Method)	iilkhjuadt(uizsyjfpxb) = xwkluaemif kkrgvnajzf (lvrzcvhqni )	Positive	15 Nov 2016
ASN2016	Not Applicable	-	-	Iohexol (Multiple Samples Method)	iilkhjuadt(uizsyjfpxb) = vqrgvfkbjm kkrgvnajzf (lvrzcvhqni )	Positive	15 Nov 2016
ASN2016	Not Applicable	Cystic Fibrosis diabetes mellitus	21	Inuline clearance	grxqfdndxv(gcgnumlxou) = wfqrffqirl mewhprimva (coxffvhtnu )	Positive	15 Nov 2016
ASN2015	Not Applicable	-	-	Different amounts of Iohexol (15 mg-150 µg/rat)	rjdjhhgbfv(uwnkzvldga) = high iohexol amounts might lead to adverse effects in organism pfuszglioj (tqqyovsurf ) View more	Positive	03 Nov 2015
FP243 (ERA2015)	Not Applicable	-	-	Iohexol	vixaqlaxha(mviqikvaer) = roywnrqilh zfuwmphppv (fztfbkkpre ) View more	Positive	21 May 2015

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