Renal Care Articles & Analysis
15 news found
” The planned study will investigate finerenone compared to placebo in addition to standard of care in approximately 220 adults with CKD and T1D. Individuals will be randomized in a 1:1 ratio to receive either finerenone or placebo in addition to standard of care, consisting of a renin-angiotensin system (RAS)-blocking therapy such as an ...
ByBayer AG
FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV morbidity and mortality in approximately 7,400 patients with CKD and T2D. ...
ByBayer AG
For study results with respect to renal and cardiovascular events, see section 5.1.” The final decision by the European Commission, authorizing marketing approval in the European Union, is expected early in 2023. ...
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
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
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
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 ...
Paul’s Hospital provides exceptional clinical care to 500,000+ patient visits each year; performs medical research that advances care around the world; and, as a teaching hospital, trains the health care professionals of tomorrow. ...
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
Most recently, he was Director, Regulatory Affairs, Devices at Fresenius Medical Care’s Renal Therapies Group. Prior to that, he provided medical device/pharmaceutical Quality Assurance and Regulatory Affairs consulting services to an international medical device manufacturer. ...
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™ ...
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
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
The initiation of the Phase III FIONA study (FInerenone for the treatment of children with chrOnic kidNey disease and proteinuriA) builds upon the robust Phase III results from the FIDELIO-DKD and FIGARO-DKD studies which evaluated the effects of finerenone versus placebo on top of standard of care across a broad range of disease severity, on both renal and ...
ByBayer AG
Safety was also shown to be similar between finerenone and placebo groups, with renal adverse events (AEs) balanced between treatment groups and low discontinuation in the finerenone group as a result of hyperkalemia AEs. ...
ByBayer AG