Torsemide vs. Furosemide for Edema Control in Children with Nephrotic Syndrome Relapses: A Single Blinded Non-Inferiority Randomized Control Trial - Nil

Start Date16 Sep 2024

Sponsor / Collaborator-

NCT06176794 / RecruitingPhase 2

A Crossover Study of Patients With Heart Failure to Compare Natriuretic Effects of Immediate Release Torsemide vs. Extended Release Torsemide Over 12 Hours After Dosing

The goal of this randomized double-blind crossover study is to assess whether a morning dose of the extended release torsemide has a better efficacy than the ordinary immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with stable heart failure. The main questions it aims to answer are:
* Are the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide different from the amounts after the immediate release torsemide.
* Are the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, different from the amounts after the immediate release torsemide.
* Is the amount of excreted sodium in the urine during the 24 hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, different from the amount after the immediate release torsemide.
Participants will be asked to:
* Start taking daily immediate release or extended release torsemide tablets that is provided to them.
* Eat the meals with standard contents of sodium that is provided to them and avoid other meals, drinks (except for water) and snacks for the duration of the study.
* Collect urine for 24 hours, after approximately one week of the initiation of the study medication.
* Go to the clinical research center the day that the 24-hour urine collection is finished and stay there throughout the day to receive standard meals and to have blood and urine samples collected.
* Switch torsemide pills to the new one that will be dispensed to them at the clinical research center. If they were taking the immediate release torsemide during the first part, then they will be given the sustained release torsemide and vice versa. The study is double blind; therefore, the subjects, study coordinators, and investigators are unaware of whether each subject is on immediate release torsemide first or on extended release torsemide first.
* Collect urine for an additional 12 hours after leaving the clinical research center to be sent to the clinical research center the next morning.
* Continue to take the provided meals and to avoid other meals, drinks (except for water) and snacks.
* Again, collect urine for 24 hours, after approximately one week, take that to the clinical research center when the 24-hour collection is completed and stay there throughout the day to receive standard meals and to have blood and urine samples collected.
* Collect urine for an additional 12 hours to be sent to the clinical research center the next morning.
Researchers will compare the amount of sodium excretion when each subject is taking immediate release torsemide versus the time that the same subject is taking extended release torsemide.

Start Date01 Jul 2024

Sponsor / Collaborator

Sarfez Pharmaceuticals, Inc.

NCT06206512 / RecruitingPhase 2

A Crossover, Double-blinded, Two-period, Double Dummy Study to Evaluate the Effects of Extended Release Torsemide in Patients With Chronic Congestive Heart Failure and Symptoms of Overactive Bladder

This research study is being done to compare the effectiveness two drugs: an extended release torsemide (ERT) versus generic immediate release Torsemide (IRT) in reducing the worsening of symptoms of Overactive Bladder (OAB i.e., frequency, urgency, or urgency incontinence) in patients with chronic congestive heart failure (CHF).
This study will include CHF patients who experience worsening OAB) symptoms with use of a loop diuretic. The total duration of the study is about eight weeks with a total of nine visits.
There will be a screening visit that lasts one to two hours. The screening visit includes history and physical exams, blood draws, and urine analysis. If eligible for the study, participants will receive either generic torsemide or extended release torsemide for the first four weeks. Participants will do a virtual research visit on week one, two and three to submit a symptom diary and answer a questionnaire about urinary symptoms. At four weeks, history and physician exam will be done and blood will be collected. Participants will be assigned to receive either extended release torsemide (if they initially received generic torsemide) and generic torsemide (if they initially received extended release torsemide) for the next four weeks. Participants will attend virtual research visits on week five, six and seven to submit a symptom diary and answer a questionnaire about urinary symptoms. At the end of the study in week eight, they will have history and physical exams and blood draws.
Some risks from the study may include side effects of torsemide like acute kidney injury, fluid/electrolyte loss, hypersensitivity reactions and reversible hearing loss/tinnitus.

Start Date01 Jun 2024

Sponsor / Collaborator

Sarfez Pharmaceuticals, Inc.

100 Clinical Results associated with Torsemide

100 Translational Medicine associated with Torsemide

100 Patents (Medical) associated with Torsemide

582

Literatures (Medical) associated with Torsemide

01 Dec 2024·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Article

Author: Gottlieb, Michael ; Moyer, Eric ; Bernard, Kyle

INTRODUCTION:

Heart failure (HF) is a common condition prompting presentation to the Emergency Department (ED) and is associated with significant morbidity and mortality. However, there is limited recent large-scale, robust data available on the admission rates, evaluation, and treatment of HF in the ED setting.

METHODS:

This was a cross-sectional study of ED presentations for HF from 1/1/2016 to 12/31/2023 using the Epic Cosmos database. All ED visits with ICD-10 codes corresponding to acute HF were included. We excluded congenital heart disease and isolated right-sided HF. Outcomes included percentage of total ED visits, admission rates, troponin, B-type natriuretic peptide (BNP), chest radiography, and diuretic and nitroglycerin medication administration. Subgroup analyses of medications were performed by medication and route of administration (transdermal, sublingual/oral, and intravenous).

RESULTS:

Out of 190,694,752 ED encounters, 2,626,011 (1.4 %) visits were due to acute HF. Of these, 1,897,369 (72.3 %) were admitted to the hospital. The majority of patients had a troponin (90.3 %), BNP (91.1 %), and chest radiograph (89.5 %) ordered. 82.5 % received intravenous diuresis, while 46.2 % received oral diuresis. The most common diuretic was furosemide (78.4 % intravenous, 32.5 % oral), followed by bumetanide (9.5 % intravenous, 7.1 % oral), and torsemide (0 % intravenous, 8.1 % oral). Nitroglycerin was given in 26.0 %, with the most common route being sublingual/oral (16.6 %), followed by transdermal (9.2 %) and intravenous (3.5 %).

CONCLUSION:

HF represents a common reason for ED presentation, with the majority of patients being admitted. All patients received diuresis in the ED, with the majority receiving intravenous diuresis with furosemide. Approximately one-quarter received nitroglycerin with the sublingual/oral route being most common. These findings can help inform health policy initiatives, including admission decisions and evidence-based medication administration.

01 Nov 2024·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Review

Author: Klein, Sandra ; Ritter, Christoph A ; Sommerfeldt, Jana ; Sartorius, Hannes ; von Sarnowski, Bettina

Abstract:

Purpose:

Drug administration via feeding tubes is considered a process with many uncertainties. This review aimed to give a comprehensive overview of data available on feeding tube application and to carry out risk assessments for drug substances commonly administered to stroke patients.

Methods:

Drugs frequently administered via feeding tubes were identified through a retrospective analysis of discharge letters from a stroke unit. Physicochemical, pharmacokinetic, and stability properties of these drugs and data on drug-enteral nutrition interactions were systematically searched for in the European Pharmacopoeia, Hagers Handbook of Pharmaceutical Practice, Birchers clinical-pharmacological data compilation, and the Martindale Complete Drug Reference, as well as from databases including DrugBank, DrugDex, PubChem, Google Scholar, and PubMed.

Results:

Of the drugs most commonly administered via feeding tubes in the present stroke patient cohort, bisoprolol, candesartan, and ramipril could be considered the least critical due to their overall favourable properties. Acetylsalicylic acid, amlodipine, hydrochlorothiazide, omeprazole and esomeprazole, simvastatin, and torasemide pose risks based on pH or light-dependent instability or proposed food effects. The most critical drugs to be administered via feeding tubes are considered to be furosemide, levodopa, and levothyroxine as they show relevant instabilities under administration conditions and substantial food effects; the latter two even possess a narrow therapeutic index. However, little information is available on drug-tube and drug-formula interactions.

Conclusion:

Feeding tube administration of medications turned out to be a highly complex process with several unmet risks. Therefore, investigations that systematically assess these risk factors using clinically relevant model systems are urgently needed.

01 Oct 2024·HYPERTENSION

UMOD Genotype-Blinded Trial of Ambulatory Blood Pressure Response to Torasemide

Article

Author: Padmanabhan, Sandosh ; MacDonald, Thomas M. ; Doney, Alexander ; Caparrotta, Thomas M. ; Mackenzie, Isla S. ; Brooksbank, Katriona ; McConnachie, Alex ; Lip, Stefanie ; Webb, David J. ; MacIntyre, Iain M. ; Dominiczak, Anna F. ; Aman, Alisha ; McCallum, Linsay ; Llano, Andrea ; Ingram, Gareth

BACKGROUND::

UMOD (uromodulin) has been linked to hypertension through potential activation of Na + -K + -2Cl − cotransporter (NKCC2), a target of loop diuretics. We posited that hypertensive patients carrying the rs13333226-AA UMOD genotype would demonstrate greater blood pressure responses to loop diuretics, potentially mediated by this UMOD/NKCC2 interaction.

METHODS::

This prospective, multicenter, genotype-blinded trial evaluated torasemide (torsemide) efficacy on systolic blood pressure (SBP) reduction over 16 weeks in nondiabetic, hypertensive participants uncontrolled on ≥1 nondiuretic antihypertensive for >3 months. The primary end point was the change in 24-hour ambulatory SBP (ABPM SBP) and SBP response trajectories between baseline and 16 weeks by genotype (AA versus AG/GG) due to nonrandomized groups at baseline ( ClinicalTrials.gov : NCT03354897).

RESULTS::

Of 251 enrolled participants, 222 received torasemide and 174 demonstrated satisfactory treatment adherence and had genotype data. The study participants were middle-aged (59±11 years), predominantly male (62%), obese (body mass index, 32±7 kg/m 2 ), with normal eGFR (92±17 mL/min/1.73 m²) and an average baseline ABPM of 138/81 mm Hg. Significant reductions in mean ABPM SBP were observed in both groups after 16 weeks (AA, −6.57 mm Hg [95% CI, −8.44 to −4.69]; P <0.0001; AG/GG, −3.22 [95% CI, −5.93 to −0.51]; P =0.021). The change in mean ABPM SBP (baseline to 16 weeks) showed a difference of −3.35 mm Hg ([95% CI, −6.64 to −0.05]; P =0.048) AA versus AG/GG genotypes. The AG/GG group displayed a rebound in SBP from 8 weeks, differing from the consistent decrease in the AA group ( P =0.004 for difference in trajectories).

CONCLUSIONS::

Our results confirm a plausible interaction between UMOD and NKCC2 and suggest a potential role for genotype-guided use of loop diuretics in hypertension management.

REGISTRATION::

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03354897.

News (Medical) associated with Torsemide

30 Nov 2022

·www.biospace.com

Novo Integrated Sciences’ Subsidiary, Clinical Consultants International, Signs Consulting Agreement with Pharmaceutical Research & Development Company, Sarfez Pharmaceuticals, Inc.

BELLEVUE, Wash.--(BUSINESS WIRE)-- Novo Integrated Sciences, Inc. (NASDAQ: NVOS) (the “Company” or “Novo”), and Clinical Consultants International LLC (“CCI”), a Novo wholly-owned subsidiary, today announced the signing of a Consulting Agreement (the “Agreement”) with Sarfez Pharmaceuticals, Inc. (“Sarfez”), a pharmaceutical research and development company with an FDA-approved edema treatment for patients with heart failure and renal disease. Dr. Joseph M. Chalil, MD, MBA, FACHE, Chief Medical Officer of Novo, stated, “Over 50% of patients with heart failure have overactive bladder problems adversely impacting their quality of life. The majority of patients with heart failure are prescribed one of three approved loop diuretics; however, patients may be exposed to worsening bladder problems due to dose adjustment risk. FDA-approved SOAANZ is a gentler loop diuretic that induces gradual and sustained diuresis for the patient over a longer period of time. Through its deep network of hospitals, physicians, and independent pharmacies for direct patient sales, CCI and the Novo team will immediately begin collaborating with Sarfez on the marketing and distribution of commercially available SOAANZ.” Sarfez’s FDA-approved, once-a-day novel formulation of loop diuretic torsemide, SOAANZ®, provides a new treatment option for patients suffering from heart failure who experience persistent edema or swelling in the lower limbs and/or abdomen. Studies have shown that SOAANZ® has a longer duration of peak effects without causing excessive urination. SOAANZ® could potentially help patients with underlying bladder sensitivities allowing the patient to skip a loop diuretic dose due to concerns with worsening bladder problems and negative impact on quality of life. About Sarfez Pharmaceuticals Sarfez Pharmaceuticals is headquartered in Vienna, VA. The pharmaceutical research and development company is focused on cardio-renal products and filling the gap at the intersection of clinical specialties that remained siloed and under-appreciated due to ever-increasing specialization in the practice of medicine. The mission of Sarfez is to develop better treatment options for patients with heart and kidney diseases, especially as they relate to a patients’ quality of life, and provide these treatments at reasonable prices while supporting small and local business including independent pharmacies. For more information on Sarfez Pharmaceuticals, please visit . About Clinical Consultants International LLC CCI, a Novo wholly owned subsidiary, was established in 2006 in Michigan as a local hospital consulting firm. Today, CCI is a global consulting firm specializing in providing value-added services for the pharmaceutical, biotech, healthcare management, hospital management, medical marketing, and strategic planning, health policy, and medical device sectors. Headquartered in Boca Raton, Florida, CCI leverages 30+ years of industry experience and its expert consultants worldwide to support clients. For more information on CCI, please visit . About Novo Integrated Sciences, Inc. Novo Integrated Sciences, Inc. is pioneering a holistic approach to patient-first health and wellness through a multidisciplinary healthcare ecosystem of multiple patient and consumer touchpoints for services and product innovation. Novo offers an essential and differentiated solution to deliver, or intend to deliver, these services and products through the integration of medical technology, diagnostic and therapeutic solutions, and rehabilitative science. We believe that “decentralizing” healthcare, through the integration of medical technology and interconnectivity, is an essential solution to the rapidly evolving fundamental transformation of how non-catastrophic healthcare is delivered both now and in the future. Specific to non-critical care, ongoing advancements in both medical technology and inter-connectivity are allowing for a shift of the patient/practitioner relationship to the patient’s home and away from on-site visits to primary medical centers with mass-services. This acceleration of “ease-of-access” in the patient/practitioner interaction for non-critical care diagnosis and subsequent treatment minimizes the degradation of non-critical health conditions to critical conditions as well as allowing for more cost-effective healthcare distribution. The Company’s decentralized healthcare business model is centered on three primary pillars to best support the transformation of non-catastrophic healthcare delivery to patients and consumers: First Pillar: Service Networks. Deliver multidisciplinary primary care services through (i) an affiliate network of clinic facilities, (ii) small and micro footprint sized clinic facilities primarily located within the footprint of box-store commercial enterprises, (iii) clinic facilities operated through a franchise relationship with the Company, and (iv) corporate operated clinic facilities. Second Pillar: Technology. Develop, deploy, and integrate sophisticated interconnected technology, interfacing the patient to the healthcare practitioner, thus expanding the reach and availability of the Company’s services, beyond the traditional clinic location, to geographic areas not readily providing advanced, peripheral-based healthcare services, including the patient’s home. Third Pillar: Products. Develop and distribute effective, personalized health and wellness product solutions allowing for the customization of patient preventative care remedies and, ultimately, a healthier population. The Company’s science-first approach to product innovation further emphasizes our mandate to create and provide over-the-counter preventative and maintenance care solutions. Innovation through science combined with the integration of sophisticated, secure technology assures Novo Integrated Sciences of continued cutting-edge advancement in patient-first platforms. For more information concerning Novo Integrated Sciences, please visit . For more information on Novo Healthnet Limited, Novo’s wholly owned subsidiary, please visit . Twitter, LinkedIn, Facebook, Instagram, YouTube Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts included in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by words such as "believe," “intend,” "expect," "anticipate," "plan," "potential," "continue," or similar expressions. Such forward-looking statements include risks and uncertainties, and there are important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These factors, risks, and uncertainties are discussed in Novo’s filings with the Securities and Exchange Commission. Investors should not place any undue reliance on forward-looking statements since they involve known and unknown uncertainties and other factors which are, in some cases, beyond Novo’s control which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects Novo’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to operations, results of operations, growth strategy and liquidity. Novo assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. The contents of any website referenced in this press release are not incorporated by reference herein.

Drug Approval

100 Deals associated with Torsemide

External Link

KEGG	Wiki	ATC	Drug Bank
D00382	Torsemide	C03CA04	DB00214

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Edema, Cardiac	JP	Mitsubishi Tanabe Pharma Corp.	12 Mar 1999
Hypertension	US	Mylan Specialty LP	09 Sep 1997
Edema	US	Mylan Specialty LP	23 Aug 1993
Edema	US	Hoffmann-La Roche, Inc.	23 Aug 1993

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic congestive heart failure	Phase 2	US	Sarfez Pharmaceuticals, Inc.	01 Jun 2024
Urinary Bladder, Overactive	Phase 2	US	Sarfez Pharmaceuticals, Inc.	01 Jun 2024
Urinary Incontinence	Phase 2	US	Sarfez Pharmaceuticals, Inc.	01 Jun 2024
Chronic Kidney Diseases	Phase 1	IN	Sarfez Pharmaceuticals, Inc.	19 Jun 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05093621 (TFO, CTgov)	Phase 3	Heart Failure	47	Furosemide (Furosemide)	jfgyerrsrh(mckdourmsn) = hpsefxdfet bobznlderg (usuelvqglb, kyvfsetzej - feaiqggvfp) View more	-	15 Oct 2024
				Torsemide (Torsemide)	jfgyerrsrh(mckdourmsn) = arjsfsxwba bobznlderg (usuelvqglb, raltzwmboj - olwxametfi) View more
NCT05093621 \| NCT03296813 (TRANSFORM-HF \| TFO, Pubmed \| J Am Soc Nephrol)	Phase 3	Hydrops Fetalis \| Heart Failure	88	Torsemide	htflqxdlmm(bldubrnbij) = wkofhmgkpl nrjcfbndpf (wkfpccctwl, 12.3% - 23.5%)	Negative	28 Aug 2024
				Furosemide	htflqxdlmm(bldubrnbij) = wioayomwkm nrjcfbndpf (wkfpccctwl, 16.6% - 34.1%)
NCT03296813 (TRANSFORM-HF, Pubmed) Manual	Phase 3	Heart Failure	2,570	Torsemide	wogwnozzax(ipxsspxhci) = apcvjqkzzl cpqhqqockz (riyojfxslk ) View more	Negative	15 May 2024
				Furosemide	wogwnozzax(ipxsspxhci) = beusydqsuf cpqhqqockz (riyojfxslk ) View more
NCT02813551 (TROPHY, CTgov)	Phase 2	Preeclamptic Toxemia	118	Torsemide (Torsemide)	mwvhwiuimc(juqklgngik) = yzgmrgqauo lhqetiooqb (oclrscaftq, wzfpljuujp - lonvhvuqeq) View more	-	10 Apr 2019
				Placebo (Placebo)	mwvhwiuimc(juqklgngik) = lnzmckcxue lhqetiooqb (oclrscaftq, obdipliqox - vilhtscduu) View more
Heart Failure Registries of the European Society of Cardiology (ESC2017)	Not Applicable	Heart Failure	-	Torasemide	mpbddtivaz(ahpsnkwtkz) = xdkrnjynkh pmbnsilvct (mkhgelezir )	-	29 Aug 2017
				Furosemide	mpbddtivaz(ahpsnkwtkz) = slbfristwt pmbnsilvct (mkhgelezir )

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