end-stage kidney disease News
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Notitia Biotechnologies Develops Revolutionary Foundation Guild Lbp for Patients With Diabetic Kidney Disease (DKD)
Notitia Biotechnologies Company has developed a ground-breaking live biotherapeutic product (LBP) for patients with early-stage and end-stage diabetic kidney disease (DKD) patients. The drug, NBT-BM306, combines the purified Foundation Guild bacteria and the tailored microbiome nutrition to support their growth in one convenient format. Notitia is preparing the Investigational New Drug (IND) ...
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Bayer to start Phase III study with finerenone in adults with chronic kidney disease and type 1 diabetes
Phase III study FINE-ONE will evaluate the efficacy and safety of finerenone versus placebo in delaying the progression of chronic kidney disease (CKD) in adults with CKD and type 1 diabetes (T1D) CKD affects up to 40% of people with T1D A quarter of people with CKD associated with T1D progress to end-stage kidney disease Only limited treatment options are available for people with CKD and ...
By Bayer AG
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Outset Medical Launches Inaugural ESG Report
Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced the release of its inaugural Environmental, Social, and Governance (ESG) report highlighting its ESG-related programs, priorities, goals, and performance. “At Outset, our ESG journey is rooted in our ...
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New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy
Exploratory analysis of the FIGARO-DKD study with finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist, indicated a reduction in renal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), as seen in the FIDELIO-DKD study Analysis of the FIDELIO-DKD study highlighted that early reduction of urine albumin-to-creatinine ratio (UACR) with ...
By Bayer AG
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Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes
Kerendia is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) The approval is based on the results of the Phase III FIDELIO-DKD study investigating the efficacy and safety of Kerendia on kidney and CV outcomes in ...
By Bayer AG
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Kerendia (finerenone) approved in China for the treatment of adults with chronic kidney disease associated with type 2 diabetes
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure and premature death Kerendia (finerenone) is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with CKD associated with T2D The approval in China ...
By Bayer AG
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Vertex Advances VX-147 Into Pivotal Clinical Development for People With APOL1-Mediated Kidney Disease
Single pivotal trial to initiate later this month targets the broad patient population with two APOL1 mutations and proteinuric kidney disease Pathway for accelerated approval using an interim analysis at Week 48 of eGFR slope, supported by reduction in proteinuria Final analysis evaluating eGFR slope at approximately two years serves as basis for U.S. approval Vertex Pharmaceuticals ...
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Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study
U.S. Food and Drug Administration (FDA) granted label update for Kerendia (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV ...
By Bayer AG
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Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes
Finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is recommended by CHMP for marketing authorization for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) CHMP opinion is based on the results of the Phase III FIDELIO-DKD study investigating the efficacy and safety of finerenone on kidney and cardiovascular outcomes in patients ...
By Bayer AG
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Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes
European Commission granted approval for a label update to extend the indication of Kerendia™ to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study FIGARO-DKD included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD ...
By Bayer AG
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Bayer receives approval in Japan for Kerendia (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure or premature death Kerendia (finerenone) is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with CKD and T2D The approval is based on the ...
By Bayer AG
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Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes
CHMP opinion is based on the results from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), which included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D The positive data from FIGARO-DKD demonstrated that finerenone significantly reduced the ...
By Bayer AG
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Bayer to present new cardiorenal data for Kerendia (finerenone) across a broad range of patients with early to late-stage chronic kidney disease and type 2 diabetes
New post-hoc analyses from the prespecified pooled analysis FIDELITY will provide insights into the effects of finerenone on kidney and cardiovascular outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline, as well as by baseline HbA1c, HbA1c variability, and diabetes duration in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) An exploratory ...
By Bayer AG
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Second Patent Issued for Healionics’ Textured STAR Biointerface
Healionics Corporation has received a further patent for its textured STAR Biointerface technology. The United States Patent and Trademark Office issued Patent No. 8,647,393, "Implantable Medical Devices Having Microporous Surface Layers and Method for Reducing Foreign Body Response to the Same.” This new patent extends the scope of 8,372,423 issued to Healionics in February 2013. The STAR ...
By Healionics
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Alkahest Announces Initiation of Phase 2 Study AKST1210-201 Exploring Treatment of Cognitive Impairment in End Stage Renal Disease Patients
Alkahest Inc., a clinical stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases, today announced the initiation of a clinical study to explore the use of an extracorporeal medical device to remove excess Beta-2 microglobulin (B2M) from circulation for the treatment of cognitive impairment in patients undergoing hemodialysis for ...
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NIH Awards Sonavex, Inc. $3 Million Grant to Pursue New Vascular Surgery Applications for EchoMark & EchoSure
Sonavex, Inc., a privately held medical device company focused on empowered patient care, announced that it received a $3 million Phase IIB Small Business Innovation Research (SBIR) grant from the National Institutes of Health to use its EchoMark & EchoSure devices to support arteriovenous (AV) fistula maturation and long-term viability. The award provides capital for prospective clinical ...
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Stanford Surgeon Venita Chandra Joins Alucent Biomedical Scientific Advisory Board as Company Enters Arteriovenous Fistula Market
Alucent Biomedical, a privately held medical technology company founded to transform the way vascular disease is treated, today announced Venita Chandra, M.D., will join the company’s scientific advisory board. Dr. Chandra is board certified in both general and vascular surgery. She is a clinical associate professor of surgery in the Division of Vascular Surgery at Stanford University ...
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Healionics Awarded $1.5M SBIR Grant from NIH to Advance Clot-Resistant Synthetic Vascular Graft for Dialysis Patients
Healionics Corporation, a Seattle-based medical device company, was awarded a $1.5M Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) to develop new vascular grafts for dialysis use that overcome the major problem of clotting failure. Andrew Marshall, Ph.D., ...
By Healionics
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Minimally Invasive Ellipsys System Creates Fused, Permanent Vascular Access for Dialysis
A new case report published in the Journal of Vascular Surgery provides one of the first known opportunities to directly visualize the permanent and fused connection (anastomosis) that is created with the minimally invasive Ellipsys® Vascular Access System. The Ellipsys System, made by Avenu Medical, creates a type of dialysis access known as a percutaneous arteriovenous fistula (pAVF) for ...
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CloudCath Announces Collaboration with American Renal Associates in Pre-Market Clinical Study for Peritoneal Dialysis Patients Innovative Remote Monitoring Platform Will Be Tested for In-Home Use
CloudCath, developer of a remote monitoring and predictive analytics platform for catheter-based treatments, today announced a collaboration with American Renal Associates (ARA), a leading provider of outpatient dialysis services. In a U.S.- based, pre-market clinical study, ARA will evaluate the use of CloudCath’s System by peritoneal dialysis (PD) patients. PD is a method of dialysis ...
By CloudCath
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