The goal of this clinical trial is to learn if calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (CKD). The main questions it aims to answer are:
* Does Sevelamer lower the progression of heart valve calcification compared to calcium carbonate over 12 months?
* What are the impacts of calcium-phosphorus regulation therapy on major cardiovascular events such as heart failure, cardiovascular death, and the need for valve surgery? Researchers will compare Sevelamer to calcium carbonate to see if Sevelamer is more effective in reducing heart valve calcification.
Participants will:
* Take Sevelamer or calcium carbonate daily for 12 months.
* Undergo echocardiography and CT scans at baseline and after 12 months to assess heart valve calcification.
* Attend follow-up visits at 3, 6, 9, and 12 months to monitor blood tests and adjust treatment as needed.

Start Date01 Mar 2024

Sponsor / Collaborator

National Center for Cardiovascular Diseases

TCTR20230530004 / CompletedPhase 4IIT

Protein-bound uremic toxin lowering effects of sevelamer in end-stage kidney disease receiving hemodialysis with hyperphosphatemia: a randomized controlled trial

Start Date25 Jul 2023

Sponsor / Collaborator

University of Chulalongkorn

[+1]

IRCT20200724048193N1 / CompletedPhase 4IIT

Comparing the Effect of Sevelamer Hydrochloride and Calcium Carbonate on Serum Level of hs-CRP, Soluable CD-14 and Endotoxin in Hemodialysis Patients

Start Date22 Oct 2020

Sponsor / Collaborator

Tabriz University of Medical Sciences

100 Clinical Results associated with Sevelamer Hydrochloride

100 Translational Medicine associated with Sevelamer Hydrochloride

100 Patents (Medical) associated with Sevelamer Hydrochloride

364

Literatures (Medical) associated with Sevelamer Hydrochloride

01 Mar 2024·Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis

Biochemical markers of iron status and iron accumulation in peritoneal dialysis patients treated with ferric citrate

Article

Author: Lea, Janice I ; Ajiboye, Oyintayo ; Navarrete, José E

Background::

Hyperphosphataemia is a common complication of kidney disease. Current dialysis techniques do not provide enough phosphorus clearance, hence the need to use phosphorus binders. Treatment options include calcium carbonate, calcium acetate, lanthanum carbonate, sevelamer hydrochloride and iron-based binders. Patients receiving peritoneal dialysis (PD) with sustained elevated ferritin levels exceeding 800 ng/mL are at a higher risk of death. We identify PD patients treated with iron-based binders and compare ferritin and risk of iron accumulation to patients treated with non-iron-based binders.

Methods::

All records of patients receiving PD at Emory dialysis centres until 30 October 2021 were reviewed for phosphorus binders. Basic demographics and laboratory data were time-referenced to the days on treatment with a particular binder. Patients were followed until discontinuation of the phosphorus binder, death, transplant, transfer to another dialysis provider or censoring at 36 months after medication was started.

Results::

Compared to calcium acetate and sevelamer, ferric citrate utilisation in PD patients resulted in a sustained increase in ferritin. The proportion of patients with a ferritin equal to or greater than 800 ng/dL and transferrin saturation greater than 40% increased over time in patients treated with ferric citrate and was higher during the second and third year of follow-up compared to baseline values and to patients treated with calcium acetate or sevelamer. Two patients (7%) treated with ferric citrate developed clinically significant haemosiderosis.

Conclusions::

Use of ferric citrated in PD resulted in significant iron accumulation as judged by ferritin levels.

01 Oct 2023·Endocrinology, diabetes & metabolism case reports

Elderly-onset calcinosis of hyperphosphataemic familial tumoural calcinosis/hyperostosis-hyperphosphataemia syndrome: the role of comorbid scleroderma

Article

Author: Iwasaki, Hiroaki

Summary:

A 73-year-old woman with type 2 diabetes mellitus was referred to our department for glycaemic control. Physical examination revealed two subcutaneous hard masses around the left shoulder and the right hip joint. The patient could not fully extend her fingers because of skin sclerosis in both hands. Laboratory studies showed hyperphosphataemia and a high ratio of renal tubular maximum reabsorption of phosphate to glomerular filtration rate. There were no abnormalities in serum calcium, creatinine, alkaline phosphatase, and intact parathyroid hormone levels, whereas serum fibroblast growth factor 23 was low. Hyperphosphataemic familial tumoural calcinosis/hyperostosis-hyperphosphataemia syndrome (HFTC/HHS) was diagnosed using whole genome sequencing that revealed a novel frameshift beyond the 584th threonine located in the lectin domain of UDP-N-acetyl-alpha-D-galactosamine:polypeptide N-acetylgalactosaminyltransferase 3 associated with a duplication of the 1748th thymine in the coding region of the corresponding gene. Furthermore, anti-nuclear, anti-centromere, and anti-cardiolipin antibodies were positive, implying that comorbid limited type scleroderma might play a role in tumoural calcinosis (TC) development. A low phosphate diet was prescribed with phosphate-lowering medications, including aluminium hydroxide, acetazolamide, and sevelamer hydrochloride. The patient displayed a decrease in serum phosphate levels from 6.5 to 5.5 mg/dL 10 months after the initiation of treatment, but her TC had not improved during treatment for more than 1 year. This case was interesting because the patient with HFTC/HHS exhibited TC despite being over her 60s, and subsequent scleroderma might contribute to the specific clinical course. When HFTC/HHS presents with elderly-onset TC, the involvement of comorbidities in exacerbating TC should be considered.

Learning points:

HFTC/HHS occurs on an autosomal recessive basis, but its clinical course and manifestations differ significantly throughout the cases.HFTC/HHS may be undiagnosed until later in life because of its rarity, unfamiliarity, and phenotype diversity; therefore, HFTC/HHS should be included in the differential diagnosis of elderly patients with unexplained hyperphosphataemia or ectopic calcinosis.Comorbidities, including rheumatologic disorders, may contribute to developing HFTC/HHS-associated calcinosis.

04 Jul 2023·Drug and chemical toxicology

In vitro cytogenetic analysis of two different anti-phosphates (sevelamer hydrochloride and calcium carbonate) agents used by patients with hyperphosphatemia

Article

Author: İla, Hasan Basri ; Ulaya, Goulzar

Sevelamer hydrochloride (SH) and calcium carbonate (CaCO₃) are two agents included in the phosphate-binding group which are frequently prescribed in the treatment of patients with hyperphosphatemia. However, there are no satisfactory studies on the genotoxic effects of SH in vitro. This study was conducted to reveal the genotoxic and/or cytotoxic potential of these two drugs in cultured human peripheral lymphocytes. Human peripheral lymphocytes were treated with SH and CaCO₃ at sublethal concentrations for 24 or 48 h for micronucleus assay and 1 h in the comet assay. CaCO₃ and SH stimulated a slight increase in micronucleus formation however this increase was not significant compared to the control group. According to the findings of the comet test, only one concentration of the SH caused significant DNA damage (2 mg/ml, 48 h) whereas CaCO₃ did not cause important DNA breakage. No significant oxidative damage or anti-radical effect caused by test substances was observed on the pure pBR322 plasmid DNA in a cell-free medium. Also, it was found that the drugs were devoid of mutagenic activity in the Ames test, but had a weak cytotoxic effect. Both test substances, particularly SH, significantly reduced the nuclear division index compared to the control group. In conclusion, the cytotoxic effect of SH was evident on the basis of in vitro tests and slightly higher than CaCO₃.

News (Medical) associated with Sevelamer Hydrochloride

05 Jun 2023

·www.globenewswire.com

Carina Biotech Appoints Two New U.S. Based Biotechnology Executives to the Board of Directors

ADELAIDE, Australia, June 05, 2023 (GLOBE NEWSWIRE) -- Carina Biotech (Carina), a cell therapy immuno-oncology company, today announced the appointment of Michael S. Wyzga, M.B.A., and Remus Vezan M.D., Ph.D., to its Board of Directors. Mr. Wyzga is an accomplished biotechnology executive who brings to Carina’s Board over two decades of expertise as a leader and advisor to life sciences companies. Dr. Vezan is an oncology leader who has had immeasurable success in the advancement of numerous cell therapies from early-stage development through commercialization, including a CAR-T cell therapy for hematologic malignancies, which was also one of the first U.S. Food and Drug Administration (FDA) approved CAR-T cell therapies. “We are delighted to welcome two seasoned executives that bring a wealth of expertise in the U.S. biotechnology industry as independent Directors to the Carina Board,” remarked Leanna Read, Ph.D., Chair of Carina’s Board of Directors. “Mike’s track record in the life sciences industry and Remus’ cell therapy clinical developmental expertise will be invaluable as we commence a Phase 1/2a clinical trial for our lead CNA3103 in metastatic colorectal cancer (mCRC) after receiving U.S. IND clearance earlier this year. It is a pivotal time for Carina as CNA3103 advances into clinical development and we look forward to sharing the data supporting the safety and efficacy profile of our LGR5-targeted CAR-T cell therapy candidate with the international oncology community.” Mr. Wyzga is the Founder of MSW Consulting, Inc., a strategic consulting group focused on pharmaceutical and biotech industries. Previously, he served as President, CEO, and a member of the Board of Directors of Radius Health, Inc., a specialty biopharmaceutical company dedicated to bone health and expanding access for patients. Prior to that, Mr. Wyzga held numerous senior management positions at Genzyme Corporation, including as Executive Vice President and Chief Financial Officer, and played roles in the successful development and commercialization of several vital therapies, including Cerezyme for Gaucher disease, Fabrazyme for Fabry disease, Renagel for use in the treatment of hyperphosphatemia, and Campath for chronic lymphocytic leukemia. Currently, Mr. Wyzga serves on four public company Boards, including as Chairman of the Board of X4 Pharmaceuticals, GenSight Biologics, and Mereo BioPharma Group plc, as well as Chair of the Audit Committee at Invivyd, Inc. He received an MBA from Providence College and a B.S. from Suffolk University. Dr. Vezan currently serves as the Chief Medical Officer of CytoImmune Therapeutics, a clinical-stage immuno-oncology company. Prior to that, he held the positions of Chief Medical Officer of CERo Therapeutics and Executive Director of Clinical Development at Kite Pharma. At Kite Pharma, Dr. Vezan was primarily responsible for managing and overseeing the clinical development of CAR-T cell products, including axi-cell/YESCARTA®, the first CAR-T cell therapy approved for relapsed/refractory B-cell lymphoma and brexu-cell/TECARTUS®, the first CAR-T cell therapy approved for mantle cell lymphoma and adult acute lymphoblastic leukemia. Earlier, he served as Medical Director at Pharmacyclics, an AbbVie Company, where he played instrumental roles in the clinical development activities that led to the approval of Ibrutinib (IMBRUVICA®) in lymphoplasmacytic lymphomas (Waldenstrom Macroglobulinemia) and Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). He completed his medical training (M.D. and Ph.D.) at the University of Medicine and Pharmacy Cluj, Romania and University of Bern, Switzerland. Dr. Read concluded, “We would like to take this opportunity to individually thank retiring Directors Nicholas Begakis, Alexander Gosling and Charlie Latham for their guidance through the start-up phases of Carina Biotech. Their insight and contribution have been invaluable.” Mr. Gosling will continue to support Carina on the Governance, People and Remuneration Committee, whilst Mr. Latham will remain Company Secretary. About CNA3103Carina’s proprietary CNA3103 CAR-T cell targets LGR5, a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients, LGR5 expression has been correlated with poor prognosis. Cancer stem cells are a small sub-population of cells within a tumor with the ability to self-renew, differentiate into the many cell types of a tumor, initiate new tumors, and resist chemotherapy and radiotherapy (leading to relapses). By targeting cancer stem cells, it is hoped that this therapy will reduce the tumor’s ability to generate new cancer cells, resulting in durable tumor suppression and preventing the relapses that are very common in patients with colorectal cancer. Carina’s pre-clinical studies of CNA3103 have shown promising results with complete tumor regression and no tumor recurrence following a single administration. CNA3103 has also demonstrated impressive tumor access and prolonged survival, enabling rejection of new tumors in pre-clinical studies. About Carina BiotechImmuno-oncology company Carina Biotech is developing CAR-T and other adoptive cell therapies for the treatment of solid cancers. In addition to its LGR5-targeted CAR-T cell therapy CNA3103 for advanced colorectal cancer, Carina has a deep pipeline of CAR-T programs. Using its proprietary chemokine receptor platform, Carina aims to improve access to and infiltration of solid cancers by CAR-containing cells, resulting in more potent and specific cancer killing and reduced off-target effects.Carina also has a fully integrated, proprietary manufacturing process that has both reduced manufacturing time and improved CAR-T cell quality, capable of delivering robust “serial-killing” CAR-T cells to patients. For more information please contact: Deborah Rathjen, PhD Rudi MichelsonCEO & Managing Director Monsoon Communications Carina Biotech +61 (0)3 9620 3333+61 418 160 425rudim@monsoon.com.au deborah@carinabiotech.com Stephanie Carrington ICR Westwicke +1 646 277 1282 stephanie.carrington@westwicke.com

Executive ChangeCell TherapyImmunotherapyDrug Approval

30 Mar 2023

·www.businesswire.com

Glyscend Therapeutics Appoints Biotech Industry Veteran Michael Wyzga to its Board of Directors

BOSTON--( BUSINESS WIRE )-- Glyscend Therapeutics , a clinical-stage biotechnology company pioneering a new generation of orally administered polymer therapies, today announced the appointment of Michael Wyzga to its Board of Directors. Mr. Wyzga brings over two decades of deep experience leading and advising life sciences companies to the Glyscend Board. “We are thrilled to welcome Mike, a distinguished biotech industry expert, to the Glyscend team,” said Ashish Nimgaonkar, M.D., President and CEO of Glyscend. “As we continue to progress our lead asset, GLY-200, through clinical development, his broad experience in leadership roles across the areas of finance, strategic planning and corporate development will be invaluable. I, along with the rest of the Board, look forward to his partnership.” Mr. Wyzga added, “I’m pleased to join the Glyscend Board of Directors during this exciting time for the company. With encouraging findings observed with GLY-200 in Glyscend’s Phase 1 trial, I believe this drug, with its unique, gut-targeted approach, could provide a promising option to help patients achieve glycemic and bodyweight control in a highly convenient and safe manner. I look forward to working with Glyscend’s expert management team as the company continues to develop an innovative treatment option for Type 2 diabetes and obesity.” Mr. Wyzga is the President of MSW Consulting, Inc., a private company focused on strategic biotechnology consulting, a position he has held since November 2013. Prior to that, he served as President, CEO and a member of the Board of Directors of Radius Health, Inc. From 1993 to 2011, Mr. Wyzga served in various senior management positions at Genzyme Corporation, including as Executive Vice President, Finance and as Chief Financial Officer. During his time with Genzyme, Mr. Wyzga played key roles in the successful development and commercialization of several important therapies, including Cerezyme for Gaucher disease, Fabrazyme for Fabry disease, Renagel for use in the treatment of hyperphosphatemia and Campath for chronic lymphocytic leukemia. Mr. Wyzga has served on many public company Boards, including at Invivyd, Inc., Mereo BioPharma Group plc, OncoMed Pharmaceuticals, Inc., X4 Pharmaceuticals, GenSight Biologics, LogicBio Therapeutics, Akebia Therapeutics, Inc., Idenix Pharmaceuticals, Inc., Prosensa Holding B.V. Mr. Wyzga received an MBA from Providence College and a B.S. from Suffolk University. About Glyscend, Inc. Glyscend Therapeutics is a clinical-stage biopharmaceutical company developing novel, orally administered, polymer therapies that work on targets inside the gastrointestinal tract to treat a variety of metabolic and chronic disorders. Polymer-based therapies are a unique class of therapeutics with more than three decades of clinical experience in a wide range of applications. Glyscend’s polymer technology platform evolved out of research at Johns Hopkins University where scientists were evaluating the mechanisms that result in significantly improved glucose and metabolic regulation that precedes weight loss in certain types of metabolic surgery. The company’s lead product candidate, GLY-200, is in clinical development initially for the treatment of Type 2 diabetes and/or obesity. In addition, Glyscend is exploring new program opportunities that address topical GI as well as systemic, inflammatory, and autoimmune conditions. The company is also investigating use of its technology platform to unlock novel GI tract targets using polymer-drug conjugates and to enhance the oral bioavailability of peptide therapies. For more information, please visit www.glyscend.com .

Phase 1Executive Change

27 Jul 2016

·medcitynews.com

Tricida raises $55M to prep trials, commercial path for kidney drug

Patients who have chronic kidney disease face permanent kidney damage and the prospect of end-stage renal failure. Clinical-stage drug developer Tricida is trying to bring patients who suffer from this condition a new treatment and it now has $55 million in new capital to continue its work. The Series C round brings the South San Francisco, California-based company’s total fundraising haul to $95 million. It comes 16 months after the company closed a $30 million Series B round. New investor Longtitude Capital led the latest round, joined by another new investor, Vivo Capital. Existing investors OrbiMed, Sibling Capital Ventures, and Limulus Venture Partners also participated in the Series C investment. Tricida declined to comment about the funding beyond its news release, which said that the capital will be used to finance late-stage clinical trials of its lead drug candidate, TRC101. Tricida is currently evaluating its compound in 100 patients in a Phase 1/2 clinical trial, which combines the first two phases of clinical trials in a single study. In the news release, the company said that trial is nearing completion and that Tricida is preparing for a Type B meeting with the Food and Drug Administration later this year to discuss the compound’s safety and efficacy in the study. Type B meetings are held at the end of a Phase 2 study and in advance of a Phase 3 trial. The FDA typically schedules these meetings within 60 days of a written request. Chronic kidney disease is damage to kidneys that can be caused by diabetes and high blood pressure, according to the American Kidney Fund. The organization estimates that 31 million Americans are living with the condition. Chronic kidney disease causes permanent damage that can worsen over time, potentially leading to kidney failure or end-stage renal disease. Patients whose kidneys fail need dialysis or a kidney transplant. Tricida said on its website that one of the characteristics of chronic kidney disease is the accumulation of electrolytes that are produced by the body’s natural metabolic and dietary processes. These electrolytes include phosphate, potassium, and sodium. Tricida said that TRC101 treats chronic kidney disease by restoring the balance of such electrolytes. Other drugs are drugs available to restore electrolyte imbalance, including Renagel and Renvela, both marketed by Sanofi. Chronic treatments for end-stage renal disease patients generate nearly $1 billion in global sales, according to Tricida. Like the Sanofi drugs, TRC101 isn’t absorbed by the body, Tricida said. The Tricida drug is designed to work in the gastrointestinal tract. Because the drug is not broken down and absorbed by the body but is instead cleared by the digestive system, Tricida said this non-absorbed feature could improve the compound’s safety profile. The drug would be used in patients who have not yet reached the point of needing dialysis treatment. TRC101 is the product of Tricida’s own in-house drug discovery, and the company has moved quickly in its development efforts. Less than two years ago, Tricida announced that it discovered TRC101, which it said it would pursue as a potential treatment for diseases of the heart and kidneys. In March 2015, Tricida announced its $30 million Series B round, which the company used to lay the groundwork for clinical testing in chronic kidney disease. Tricida CEO Gerrit Klaerner said this week that the company is ahead of schedule in establishing the compound’s clinical proof of concept. Now the company is already looking beyond late-stage studies as it considers the drug’s commercialization plans. “The company’s anticipated development path and commercial positioning in pre-dialysis patients allow us to consider multiple options, including eventually launching TRC101 with our own sales force,” Dr. Klaus Veitinger, chairman of Tricida’s board of directors and a venture partner at investor OrbiMed, said in a prepared statement.

100 Deals associated with Sevelamer Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01983	Sevelamer Hydrochloride	V03AE02	DB00658

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Kidney Disease-Mineral and Bone Disorder	EU	Genzyme Europe BV	25 Feb 2015
Chronic Kidney Disease-Mineral and Bone Disorder	IS	Genzyme Europe BV	25 Feb 2015
Chronic Kidney Disease-Mineral and Bone Disorder	LI	Genzyme Europe BV	25 Feb 2015
Chronic Kidney Disease-Mineral and Bone Disorder	NO	Genzyme Europe BV	25 Feb 2015
Chronic Kidney Diseases	AU	Sanofi-Aventis Australia Pty Ltd.	30 Jun 2005
Hyperphosphatemia	EU	Sanofi	28 Jan 2000
Hyperphosphatemia	IS	Sanofi	28 Jan 2000
Hyperphosphatemia	LI	Sanofi	28 Jan 2000
Hyperphosphatemia	NO	Sanofi	28 Jan 2000
Kidney Failure, Chronic	US	Genzyme Corp.	30 Oct 1998

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Phase III Study (ASN2015)	Phase 3	Hyperphosphatemia	213	PA21 (Sucroferric Oxyhydroxide)	pwtvzyqnic(mmvzvlodyd) = ofknjoqfwe ulgrylqwvz (udorowxyce ) View more	Positive	03 Nov 2015
				Sevelamer Hydrochloride	pwtvzyqnic(mmvzvlodyd) = awtrialelh ulgrylqwvz (udorowxyce ) View more
SP395 (ERA2015)	Not Applicable	Uremia Maintenance SOD \| MDA \| AGEs	111	Sevelamer based PB	dkvlnaqbwc(vkqqwymjfl) = tuqdskulgb hesjqhpbtt (jrcfvtxatk ) View more	Positive	21 May 2015
				Calcium based PB	dkvlnaqbwc(vkqqwymjfl) = misozlqtzo hesjqhpbtt (jrcfvtxatk ) View more
J-DOPPS (ERA2014)	Not Applicable	Add-on	-	Sevelamer	mpzutcntbj(lveolufroz) = nrzjcailfn nrpziuuymj (qpoysoxkga )	Positive	01 May 2014
				No Sevelamer	mpzutcntbj(lveolufroz) = ncjdloxjhf nrpziuuymj (qpoysoxkga )
ASN2011	Not Applicable	Hyperphosphatemia Maintenance	138	Sevelamer Hydrochloride	icdojlptut(ezljsqgmdn) = Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.12% patients ciurvbthaf (hwhblposim )	Positive	08 Nov 2011
SBR759 (ASN2010)	Phase 3	-	203	SBR759	hikxhutzpf(onxcesencv) = more frequent with SBR759 updxeiwimy (pdczmlgkuz ) View more	Positive	16 Nov 2010
				Sevelamer-HCl
SBR759 (ASN2010)	Phase 2	-	203	SBR759 3.0g	ldjwgektqg(inisvvzocq) = Similar incidences of SAE/AE were seen with SBR759 and S-HCl (5.2/90.3% vs 4.4/94.1%); no SAE was drug-related. Overall discontinuation rates were lower with SBR759 (11.9% vs 20.6%) as well as discontinuation due to AE (3.7% vs 13.2%). Most frequent AE category with SBR759 and S-HCl was gastrointestinal (GI) disorders (57.5% vs 64.7%). GI AE intensity was mostly mild with SBR759 (mild 45.5%, moderate 11.2%; severe 0.7%) whereas with S-HCl more moderate and severe AEs were reported (mild 30.9%; moderate 27.9%; severe 5.9%). Diarrhea AEs were more frequent with SBR759 (19.4% vs 10.3%); constipation and abdominal distension affected more patients on S-HCl (5.2% and 25.0% vs 3.0% and 25.0%, respectively). Based on Deficiency of Acquired Immune Deficiency Syndrome (DAIDS) grading, majority of diarrhea AE were of grade 1 (lowest severity) with SBR759 and S-HCl (18.7% vs 10.3%) tvspyizsrz (bkgwotrcrx )	Positive	16 Nov 2010
				Sevelamer Hydrochloride 2.4g
ASN2010	Not Applicable	Stiffness	484	Sevelamer Hydrochloride (SE)	dmjxwrbblx(ybtgneqihi) = eddirattuu osfqufqzjq (pacarsggyz ) View more	Positive	16 Nov 2010
				Sevelamer Hydrochloride (Non-SE)	dmjxwrbblx(ybtgneqihi) = lenqlvavyx osfqufqzjq (pacarsggyz ) View more

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