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Chronic Renal 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
In the prospective observational XARENO study, after a two year follow up period, Xarelto was associated with a reduced risk of adverse kidney outcomes and all-cause mortality in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD), compared to vitamin K antagonists (VKA) XARENO evaluated the impact of Xarelto in patients with NVAF ...
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
Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two completed and published studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease ...
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 ...
Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two completed and published studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease ...
ByBayer AG
Bodyport, a medtech company based in San Francisco, developed the Bodyport Cardiac Scale, a set of weighing scales that can non-invasively assess fluid status and heart function. The scales can detect these signals through the feet when a patient steps onto the device. The technology is intended to be convenient and requires only 20 seconds each morning, and should easily lend itself to ...
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 ...
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 ...
Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is approved for the treatment of chronic kidney disease and type 2 diabetes, excluding patients with end-stage renal disease or on dialysis. ...
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™ ...