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Chronic Kidney Failure Articles & Analysis
39 news found
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 ...
ByBayer AG
The XARENO study results provide important evidence that can help physicians in the management of patients with atrial fibrillation and chronic kidney disease and help reduce patients’ risk of progressing to kidney failure,” said Reinhold Kreutz, Professor of Clinical Pharmacology, Charité - ...
ByBayer AG
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 ...
ByBayer AG
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 ...
ByBayer AG
FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately ...
ByBayer AG
Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company, today announced that it will be carrying out an NIH-sponsored Phase I study of Bioflux-AI, Biotricity’s innovative artificial intelligence-driven (‘AI’) system of real-time monitoring and prediction technology, in subjects with ...
FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately ...
ByBayer AG
Cardiac monitoring is especially helpful in those living with advanced heart disease, such as heart failure. There are over 6 million Americans living with heart failure and approximately 1 million heart failure hospitalizations a year, with 90% of heart failure hospitalizations due to worsening hemodynamic congestion. ...
FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately ...
ByBayer AG
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will present at the following investor conferences: H.C. Wainwright Global Investment Conference Wednesday, May 25, 2022, at 10:30 a.m. ...
First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients First launches in Europe expected in H2 2022 Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Commission has granted marketing authorization to Kapruvia® (difelikefalin) for the ...
Invizius Limited (“Invizius”), a biotechnology company developing treatments to suppress unwanted immune responses in haemodialysis, today announces that it has been awarded a second Biomedical Catalyst grant (Feasibility & Primer Award) by Innovate UK to research a new field of application for its H-Guard technology. Globally there are 3.5 million patients who are ...
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on Monday, April 11, 2022, at 1:30 p.m. ET. ...
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced biomarker data from the KALM-1 and KALM-2 clinical trials evaluating KORSUVA™ (difelikefalin) injection for the treatment of chronic kidney disease-associated pruritus in patients undergoing ...
“There is a high burden of type 2 diabetes in Japan, and a large proportion of people with type 2 diabetes develop chronic kidney disease. Despite well-controlled blood glucose levels and blood pressure, patients with chronic kidney disease and type 2 diabetes remain at risk of chronic ...
ByBayer AG
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced data from a sub-study of the KARE Phase 2 clinical trial demonstrated Oral KORSUVA™ (difelikefalin) improved itch and inflammatory biomarkers in atopic dermatitis (AD) patients with ...
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 ...
Oral presentation will include biomarker data from KARE Phase 2 clinical trial of Oral KORSUVA™ (difelikefalin) for the treatment of moderate-to-severe pruritus in atopic dermatitis patients Oral KORSUVA (difelikefalin) Phase 3 pruritus programs in non-dialysis dependent advanced chronic kidney disease and atopic dermatitis, respectively, to be discussed during Company’s virtual ...
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will present at the following investor conferences in May: BofA Securities 2022 Healthcare Conference Tuesday, May 10, 2022, at 2 p.m. ...
Committee for Medicinal Products for Human Use (CHMP) recommends approval of Kapruvia® (difelikefalin) as first therapy in Europe for the treatment of chronic kidney disease associated-pruritus (CKD-aP) in hemodialysis patients European Commission decision for EU Marketing Authorization is expected in Q2 2022 Kapruvia® is approved in the U.S. under the trade name KORSUVA™ ...