[Translation] A single-dose, randomized, open-label, two-dose, two-period, crossover, fasting bioequivalence pilot study of iron sucrose injection in Chinese healthy subjects

主要目的：比较空腹状态下，健康受试者单次静脉注射石药集团欧意药业有限公司生产的蔗糖铁注射液（受试制剂）与IDT Biologika GmbH公司生产Vifor (international) Inc.持证的蔗糖铁注射液（商品名：维乐福®，参比制剂）后的生物等效性，为正式试验设计提供数据参考。次要目的：观察空腹状态下，健康受试者单次静脉注射受试制剂和参比制剂后的安全性。

[Translation]

Primary objective: To compare the bioequivalence of a single intravenous injection of iron sucrose injection (test preparation) produced by CSPC Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. and a certified iron sucrose injection (trade name: Vifor®, reference preparation) produced by IDT Biologika GmbH in healthy subjects under fasting conditions, and to provide data reference for formal trial design. Secondary objective: To observe the safety of a single intravenous injection of the test preparation and the reference preparation in healthy subjects under fasting conditions.

Start Date07 Mar 2024

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

NCT06366698 / RecruitingPhase 3

Randomized Control Trial: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia in Pregnancy

This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded.

Start Date21 Nov 2023

Sponsor / Collaborator

Arrowhead Regional Medical Center

100 Clinical Results associated with Iron sucrose

100 Translational Medicine associated with Iron sucrose

100 Patents (Medical) associated with Iron sucrose

1,178

Literatures (Medical) associated with Iron sucrose

01 Mar 2024·The Science of the total environment

Nanoparticles synergy: Enhancing wheat (Triticum aestivum L.) cadmium tolerance with iron oxide and selenium

Article

Author: Abdel-Maksoud, Mostafa A ; Okla, Mohammad K ; Abbas, Zahid Khorshid ; Chen, Fu ; Jiang, Feifei ; Al-Harbi, Nadi Awad ; Gómez-Oliván, Leobardo Manuel ; Al-Qahtani, Salem Mesfir

Nanotechnology is capturing great interest worldwide due to their stirring applications in various fields and also individual application of iron oxide nanoparticle (FeO - NPs) and selenium nanoparticles (Se - NPs) have been studied in many literatures. However, the combined application of FeO and Se - NPs is a novel approach and studied in only few studies. For this purpose, a pot experiment was conducted to examine various growth and biochemical parameters in wheat (Triticum aestivum L.) under the toxic concentration of cadmium (Cd) i.e., 50 mg kg^-1 which were primed with combined application of two levels of FeO and Se - NPs i.e., 15 and 30 mg L^-1 respectively. The results showed that the Cd toxicity in the soil showed a significantly (P < 0.05) declined in the growth, gas exchange attributes, sugars, AsA-GSH cycle, cellular fractionation, proline metabolism in T. aestivum. However, Cd toxicity significantly (P < 0.05) increased oxidative stress biomarkers, enzymatic and non-enzymatic antioxidants including their gene expression in T. aestivum. Although, the application of FeO and Se - NPs showed a significant (P < 0.05) increase in the plant growth and biomass, gas exchange characteristics, enzymatic and non-enzymatic compounds and their gene expression and also decreased the oxidative stress, and Cd uptake. In addition, individual or combined application of FeO and Se - NPs enhanced the cellular fractionation and decreases the proline metabolism and AsA - GSH cycle in T. aestivum. These results open new insights for sustainable agriculture practices and hold immense promise in addressing the pressing challenges of heavy metal contamination in agricultural soils.

01 Feb 2024·Journal of environmental management

Iron oxyhydroxide catalyzes production of artificial humic substances from waste biomass

Article

Author: Liu, Yongqi ; Su, Xintai ; Zhou, Hao ; Kouznetsova, Tatyana ; Chen, Xinyu ; Ratko, Alexander A ; Ivanets, Andrei ; Yang, Bo ; Fu, Xinying ; Boguta, Patrycja ; Zhao, Dongmei ; He, Xiaoyan

Production of artificial humic substances (AHS) from waste biomass will contribute to environmental protection and agricultural productivity. However, there is still a lack of a faster, more efficient and eco-friendly way for sustainable production. In this study, we proposed a method to accelerate the production of AHS from cotton stalks by mild pyrolysis and H₂O₂ oxidation in only 4 hours, and investigated the formation of AHS during biomass transformation. We found that the process increased the aromatic matrix and facilitated biomass transformation by enhancing the depolymerization of lignin into micromolecular phenolics (e.g., guaiacol, p-ethyl guaiacol, etc.). The optimum conditions of pyrolysis at 250 °C and oxidation with 6 mL H₂O₂ (5 wt%) yielded up to 19.28 ± 1.30 wt% artificial humic acid (AHA) from cotton stalks. In addition, we used iron oxyhydroxide (FeOOH) to catalyze biomass transformation and investigated the effect of FeOOH on the composition and properties of AHS. 1.5 wt% FeOOH promoted the increased content of artificial fulvic acid (AFA) in AHS from 10.1% to 26.5%, eventually improving the activity of AHS. FeOOH raised the content of oxygen-containing groups, such as carboxylic acids and aldehyde, and significantly increased polysaccharide (10.94%-18.95%) and protein (1.95%-2.18%) derivatives. Polymerization of amino acid analogs and many small-molecule carbohydrates (e.g., furans, aldehydes, ketones, and their derivatives) promoted AFA formation. Finally, carbon flow analysis and maize incubation tests confirmed that AHS were expected to achieve carbon emission reductions and reduce environmental pollution from fertilizers. This study provides a sustainable strategy for the accelerated production of AHS, which has important application value for waste biomass resource utilization.

01 Jan 2024·Pediatric blood & cancer

Intravenous iron for critically ill children. Comparison of three dose regimens

Article

Author: Santiago Lozano, María José ; de la Mata Navazo, Sara ; Sánchez Galindo, Amelia Caridad ; Butragueño-Laiseca, Laura

Abstract:

Background:

Anemia is extremely common among patients admitted to pediatric intensive care. Alternative treatments to transfusions such as intravenous iron must be considered. There are no published data for a prospective intravenous (IV) iron study focused in the critically ill children. The objective is to examine the safety and efficacy of intravenous iron sucrose infusion to manage anemia in pediatric critical care. A secondary objective is to examine the effect of different dose regimens of iron sucrose (3, 5, and 7 mg/kg dose).

Procedure:

Prospective investigation of intravenous iron sucrose utilization at a tertiary pediatric intensive care unit between October 2017 and November 2022.

Results:

In all 115 patients received a total of 616 infusions of IV iron. Transferrin saturation index (TSI) was the most common altered iron deficiency biomarker (91.8%). After IV iron treatment, hemoglobin showed a significant increase within a 30‐day follow‐up (9.2 vs. 11.6 g/dL, p < .001). There was also a significant improvement in TSI and serum iron (p < .001). Iron deficit replacement was higher in the 7 mg/kg dose group (94%) compared to 85.9% in the 5 mg/kg regimen and 77.5% in the lower dose group (p = .008), requiring less doses and a shorter time. Very few mild adverse reactions were reported (1.3% of infusions), with no differences between groups. The most frequent adverse effect was gastrointestinal in three cases. There were no anaphylaxis‐like or other serious/life‐threatening adverse effects.

Conclusions:

This is the first study to evaluate intravenous iron therapy in pediatric critical care, providing preliminary evidence of safety and efficacy of IV iron sucrose. The 7 mg/kg dose regimen showed higher iron deficit replacement in a shorter time, which could be beneficial in critically ill children.

News (Medical) associated with Iron sucrose

26 Apr 2024

·www.prnewswire.com

Renibus Therapeutics Announces Oral Presentations on RBT-1 at AATS and SCA Medical Conferences

SOUTHLAKE, Texas, April 26, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced its participation at two prestigious medical conferences: the American Association for Thoracic Surgery (AATS) 104th Annual Meeting and the Society of Cardiovascular Anesthesiologists (SCA) 46th Annual Meeting, both taking place in Toronto, Canada, April 27-30, 2024. "We are pleased to present additional clinical data on RBT-1 at the AATS and SCA meetings in collaboration with key opinion leaders in our field, Drs. Charles Mack and Andrew Shaw," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "These presentations are critical to advancing the understanding of our preconditioning approach with RBT-1, and we thank the meeting organizers and principal investigators for their partnership. Our Phase 3 PROTECT study is enrolling well and we remain on track to report top-line data in the third quarter of 2025." RBT-1 (stannic protoporfin / iron sucrose) is a single dose, multi-organ, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing cardiac surgery.Renibus Therapeutics is actively enrolling its PROTECT Phase 3 pivotal trial evaluating RBT-1's potential to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received both FDA Breakthrough and Fast Track Designations. Details of the oral presentations at AATS: Title: RBT-1 Reduces Incidence of Blood Product Utilization in Patients Undergoing Non-Emergent Coronary Artery Bypass Grafting and/or Valve Surgery Date and Time: Sunday, April 28th at 9:44 am ET Location: Room 714 Presenter: Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine Title: RBT-1 Reduces the Number of Post-Operative Complications Associated with Cardiac Surgery Date and Time: Sunday, April 28th at 4:03 pm ET Location: Theater 2, Exhibit Hall Presenter: Bhupinder Singh, MD, Chief Medical Officer, Renibus Details of the oral presentation at SCA: Title: RBT-1 Improves Clinical Outcomes in Patients Requiring Prolonged Intensive Care Unit Stay Following Non-Emergent Cardiac Surgery Date and Time: Sunday, April 28th at 3:00 pm ET Session: Best of Meeting Oral Presenter: Andrew Shaw, MD, FRCA, FCCM, FFICM, Professor and Chair, Department of Intensive Care and Resuscitation, Cleveland Clinic About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory andantioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study. RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics

Phase 3Fast TrackPhase 2Breakthrough Therapy

18 Apr 2024

·www.prnewswire.com

Renibus Therapeutics Announces Oral Presentation on RBT-1 at the European Association for Cardio-Thoracic Surgery (EACTS) 2nd Innovation Summit

SOUTHLAKE, Texas, April 18, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced an oral presentation on RBT-1 at the prestigious, invitation only, European Association for Cardio-Thoracic Surgery (EACTS) 2nd Innovation Summit, taking place in Paris, France, April 18-20, 2024. Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery and Vice Chairman of Quality and Patient Safety, New York-Presbyterian Hospital, Weill Cornell Medicine, will be presenting on behalf of Renibus. RBT-1 (stannic protoporfin / iron sucrose) is a single dose, multi-organ, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing elective cardiac surgery. RBT-1 is actively enrolling in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received FDA Breakthrough and Fast Track Designations. "Presenting at EACTS enables Renibus to share our promising RBT-1 results with the global cardiothoracic surgery community," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "In a completed Phase 2 clinical trial, RBT-1 demonstrated the potential to improve outcomes in the post-cardiac surgery setting, including reductions in 30-day hospital readmission rates, time in the ICU, as well as time on ventilator. We continue to advance RBT-1 through the Phase 3 PROTECT study, with top-line data expected in the third quarter of 2025." Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine, added, "RBT-1 is an exciting pre-conditioning agent and I am honored to showcase its results at EACTS. While RBT-1 has demonstrated its potential benefit across multiple cardiac surgery types in its Phase 2 clinical trial, I look forward to presenting data demonstrating RBT-1's potential to have a greater impact on patients undergoing more complex procedures combining both CABG and valve surgeries where the risk of post-operative complications is greatest." Details of the oral presentation at EACTS 2nd Innovation Summit: Title: RBT-1: A Pharmacologic Approach to Reducing the Risk of Post-Operative Complications in Patients Workshop Group: Future of Extracorporeal circulation. Hypothermia in CT surgery Date and Time: Friday, April 19, 2024, 15:55 Presenter: Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory and antioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study. RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics

Phase 2Phase 3Fast TrackBreakthrough Therapy

02 Apr 2024

·www.prnewswire.com

Renibus Announces Participation at the 23rd Annual Needham Virtual Healthcare Conference

SOUTHLAKE, Texas, April 2, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal and metabolic diseases, today announced its participation in the 23rd Annual Needham Virtual Healthcare Conference, being held in a virtual format, April 8-11, 2024. Company management will meet with investors in one-on-one meetings during the conference. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics

Phase 3Fast Track

100 Deals associated with Iron sucrose

External Link

KEGG	Wiki	ATC	Drug Bank
D04616	Iron sucrose	B03AB02	DB09146

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperphosphatemia	JP	Kissei Pharmaceutical Co., Ltd.	28 Sep 2015
Chronic Kidney Diseases	US	American Regent, Inc.	06 Nov 2000
Iron deficiency	US	Allergan Sales LLC	29 Apr 1974
Anemia, Iron-Deficiency	CH	Vifor Pharma AG	02 Jun 1949

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	-	American Regent, Inc.	01 Feb 2003
Anemia	Phase 3	-	American Regent, Inc.	01 Jul 2002
Kidney Failure, Chronic	Phase 2	AT	Vifor Fresenius Medical Care Renal Pharma Ltd.	09 Jun 2017
Pediatric Crohn's Disease	Phase 2	US	American Regent, Inc.	01 Nov 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04046263 (CTgov)	Phase 4	Hyperphosphatemia \| Hypoalbuminemia \| Peritoneal Diseases	17	Sucroferric Oxyhydroxide Chewable Tablet	xflsdsftsf(rtrlwfhbnz) = nkkqwteqqo psiptglsfg (fpibsknqli, pnyhrgmaas - azgveyuymv) View more	-	31 Aug 2022
ERA2022	Not Applicable	Bone Diseases FGF23 \| soluble Klotho \| c-reactive protein (CRP) ... View more	50	Sucroferric oxyhydroxide	mhgzwxouhf(udjdtjyxac) = rnqamckliz ytbameqftu (loecelrsvm ) View more	Positive	03 May 2022
				Sevelamer	blycxayxon(xrvzudijmx) = lmmtmewzhx kzprjtfhmb (wtsaedcdpn )
MO809 (ERA2022)	Not Applicable	Hyperphosphatemia	92	Sucroferric Oxyhydroxide	imsfcpgfcg(csjujnbuew) = The drug was well tolerated zrdzibxguw (nkobtqpqoy ) View more	Positive	03 May 2022
ERA2022	Not Applicable	Bone Diseases, Metabolic skeletal plasma clearance of tracer (K i ) \| bone volume/tissue volume (BV/TV)	-	Sucroferric oxyhydroxide	tdeyfqhrdc(vzoyvlxgtd) = BV/TV (volume) was significantly lower after SO treatment than after CC treatment uuvugcmvaz (cyvtyuxzeo )	-	03 May 2022
				Calcium carbonate
ASN2021	Not Applicable	-	17	Sucroferric oxyhydroxide (SO)	pnictoktus(usucnjbjep) = bssyvbcehg wgrmfgrqlh (rcflfestel ) View more	Positive	27 Oct 2021
NCT03644264 (PA-CL-CHINA-01, BusinessWire) Manual	Phase 3	Chronic Kidney Diseases	286	Velphoro	behcrfygmr(fzrrwfquqf) = Serum phosphorus levels in patients treated with Velphoro® declined faster than in the sevelamer group and the average number of tablets taken daily (3.23) was significantly lower than with sevelamer carbonate (6.31). wxfgnrsrcj (jqbumplrkm )	Non-inferior	30 Apr 2021
				Sevelamer carbonate
NCT02707757 (CTgov)	Phase 4	Anemia	197	Iron sucrose (Iron Sucrose)	iejzziqwrn(sudotmijdl) = lstrcchxpd mesfgainnd (kwakvvfvse, cdlmuulkfz - lmbmfoxjwl) View more	-	09 Mar 2021
				Erythopoietin stimulating agent (Neorecormon)	iejzziqwrn(sudotmijdl) = lrgptpswko mesfgainnd (kwakvvfvse, afyzuidebl - buahapdpby) View more
ASN2020	Not Applicable	-	2,018	Sucroferric Oxyhydroxide (SO)	entxsokzaj(heiyimkftk) = cfskcehjia wwuagptehn (rhwszhxbur ) View more	Positive	19 Oct 2020
				Calcium Acetate	entxsokzaj(heiyimkftk) = swiixrisxn wwuagptehn (rhwszhxbur ) View more
ASN2019	Not Applicable	-	-	Low-dose (250mg/d) sucroferric oxyhydroxide (PA21)	pcslvuehzl(ogedfksuri) = redpllvfxy esiuvqlzoc (jjydjdkfjc )	Positive	05 Nov 2019
				High-dose (2000mg/d) sucroferric oxyhydroxide (PA21)	pshcomckkt(etuouslxza) = omvpimwyhv tdtbdqlojz (kabitemolm, 49 - 84) View more
ASN2019	Not Applicable	Hemodialysis complication	364	Sucroferric oxyhydroxide	bhnlswhzpm(shpmeuzavs) = ewcjfkpxjz mlcauwloeb (gukcwiiiyp )	Positive	05 Nov 2019
				Sevelamer	bhnlswhzpm(shpmeuzavs) = gsetvtamwb mlcauwloeb (gukcwiiiyp )

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Iron sucrose

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