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Kidney Function Articles & Analysis

39 news found

Bayer to start Phase III study with finerenone in adults with chronic kidney disease and type 1 diabetes

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 ...

ByBayer AG


New real world study data on reduced risk of adverse kidney outcomes for Xarelto compared to VKA

New real world study data on reduced risk of adverse kidney outcomes for Xarelto compared to VKA

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 and CKD, given that ...

ByBayer AG


Kidney and Pancreas Function Diagnostic Enzymes Are Now Available at Creative Enzymes

Kidney and Pancreas Function Diagnostic Enzymes Are Now Available at Creative Enzymes

Creative Enzymes, a global leader in diagnostic enzyme manufacturing and supply, is dedicated to offering a wide range of enzyme products as well as customized enzyme-related services for medical and research diagnosis. Recently, Creative Enzymes launched kidney and pancreas function diagnostic enzymes for the global market. The primary function of the kidney is to eliminate waste and excess ...

ByCreative Enzymes


Puzzle Medical to Present at AHA 2022 its First-in-Human Study Results

Puzzle Medical to Present at AHA 2022 its First-in-Human Study Results

Puzzle Medical Devices Inc. is delighted to announce its first-in-human results for the ModulHeart have been presented at the prestigious American Heart Association (AHA) meeting held November 5–7, 2022 at the McCormick Place Convention Center in Chicago, IL. Montreal-based Puzzle Medical Devices Inc. (PMD) developed a percutaneous heart pump designed to support cardiac and renal function ...

ByPuzzle Medical Devices Inc.


Alnylam Announces FDA Approval of Supplemental New Drug Application for OXLUMO® (lumasiran) in Advanced Primary Hyperoxaluria Type 1

Alnylam Announces FDA Approval of Supplemental New Drug Application for OXLUMO® (lumasiran) in Advanced Primary Hyperoxaluria Type 1

- OXLUMO Now Indicated for the Treatment of Primary Hyperoxaluria Type 1 (PH1) to Lower Urinary and Plasma Oxalate Levels in Pediatric and Adult Patients - - Approval is Based on Positive Efficacy and Safety Results of the ILLUMINATE-C Phase 3 Study of OXLUMO in PH1 Patients with Severe Renal Impairment, Including Those on Hemodialysis - CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 6, 2022-- Alnylam ...

ByAlnylam Pharmaceuticals, Inc.


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

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 ...

ByBayer AG


Puzzle Medical to Present at TCT 2022 Its First-in-Human Study Results for the ModulHeart™

Puzzle Medical to Present at TCT 2022 Its First-in-Human Study Results for the ModulHeart™

Montreal-based Puzzle Medical Devices Inc. (PMD) developed a percutaneous heart pump designed to support cardiac and renal function in patients with advanced heart failure (HF). PMD announced it will present its first-in-human results for the ModulHeartTM in the following session during the Transcatheter Cardiovascular Therapeutics (TCT) meeting held September 16-19, 2022 at the Boston Convention ...

ByPuzzle Medical Devices Inc.


Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in ...

BySequana Medical NV


Puzzle Medical Announces the Successful Completion of its First-in-Human Study with its ModulHeart

Puzzle Medical Announces the Successful Completion of its First-in-Human Study with its ModulHeart

Montreal-based Puzzle Medical Devices Inc., announced today the successful completion of the company’s ?rst-in-human study to evaluate the performance of its ModulHeart percutaneous heart pump designed to reduce cardiac afterload and improve renal perfusion in patients with advanced heart failure (HF). Four patients had ModulHeart deployed to provide circulatory support while undergoing ...

ByPuzzle Medical Devices Inc.


Angiodroid turns 500!

Angiodroid turns 500!

The number 500 is associated, for Italian culture, with a famous car that has marked the history of evolution and progress. We are particularly attached to this number, today more than ever. In 2021, Angiodroid exceeded 500 injectors on the market, opening up to a new age: despite the difficult times given by the Covid-19 pandemic, Angiodroid reached this milestone, which marks a new beginning ...

ByAngiodroid Spa


CO2 whenever possible: the Malaysian experience

CO2 whenever possible: the Malaysian experience

Congrats to Dr. Ismazizi B. Zaharudin and to the team of Kuala Lumpur National Heart Center – Institut Jantung Negara – for choosing CO2 as a #first contrast agent, saving the renal function of their patients. Amazing job with 40 patients treated in just a few weeks! #angiodroid #theCO2injector #ACDA #academy #CO2angiography #CO2 #procedure #zerocontrast #angiography ...

ByAngiodroid Spa


AlloVir Reports Blinded, Preliminary, Phase 2 Data Supporting the Ongoing Study of Posoleucel, a Multi-Virus-Specific T Cell Therapy, for the Treatment of BK Viremia in Kidney Transplant Recipients

AlloVir Reports Blinded, Preliminary, Phase 2 Data Supporting the Ongoing Study of Posoleucel, a Multi-Virus-Specific T Cell Therapy, for the Treatment of BK Viremia in Kidney Transplant Recipients

Phase 2 study completed enrollment ahead of schedule Posoleucel well-tolerated with no cases of graft rejection observed to date Overall decline in median BK viral load among patients completing 12 weeks of dosing with posoleucel or placebo (2:1 randomization) Posoleucel detected up to 12 weeks after last infusion Topline, unblinded study results from all 61 patients expected to be released ...

ByKalaris


Aurinia Presents Data Demonstrating LUPKYNIS (voclosporin) is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations

Aurinia Presents Data Demonstrating LUPKYNIS (voclosporin) is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, presented data demonstrating the efficacy of LUPKYNIS® (voclosporin) for the treatment of people with lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), in achieving the proteinuria ...

ByAurinia Pharmaceuticals Inc.


Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress

Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress

Use of LUPKYNIS was safe and well tolerated in patients for up to three years of treatment, with no new safety signals In AURORA 2, long-term treatment with LUPKYNIS led to a clinically relevant preservation of kidney function in LN patients A pooled analysis from the AURA-LV and AURORA 1 studies, also presented at ERA, showed early treatment response to LUPKYNIS with reductions in ...

ByAurinia Pharmaceuticals Inc.


Inversago Pharma presents data on INV-202 in Diabetic Nephropathy at the ERA 2022 Congress

Inversago Pharma presents data on INV-202 in Diabetic Nephropathy at the ERA 2022 Congress

Inversago Pharma Inc. (“Inversago”), a clinical stage biotech company with a unique portfolio of CB1 inverse agonists, announces the presentation of preclinical data at the 59th Congress of the European Renal Association (ERA), the largest annual nephrology meeting in Europe, currently held in Paris, France. These data show that INV-202, the company’s lead peripheral CB1 ...

ByInversago Pharma


CVRx Receives MR-Conditional Labeling Approval for its Barostim Heart Failure System

CVRx Receives MR-Conditional Labeling Approval for its Barostim Heart Failure System

MINNEAPOLIS, MAY 9,2022 - CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure, has received U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR) conditional labeling for its Barostim System. The Barostim System now includes instructions to allow for safe MRI scans of the head and ...

ByCVRx


New independent market research says 84% US healthcare professionals likely to use Orviglance imaging agent in target population

New independent market research says 84% US healthcare professionals likely to use Orviglance imaging agent in target population

Ascelia Pharma today announced and welcomed the results of independent market research showing that 84% of healthcare professionals will likely use Orviglance for magnetic resonance imaging (MRI) in patients with cancer in the liver and reduced kidney function. The independently conducted survey asked 270 healthcare professionals in the US (radiologists, oncologists and nephrologists) about ...

ByAscelia Pharma AB


Vertex Advances VX-147 Into Pivotal Clinical Development for People With APOL1-Mediated Kidney Disease

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 ...

ByVertex Pharmaceuticals


Ascelia Pharma successfully completes Orviglance Hepatic Impairment Study

Ascelia Pharma successfully completes Orviglance Hepatic Impairment Study

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the last patient visit has been completed in the clinical study to evaluate the effect of liver impairment on the safety, pharmacokinetics and pharmacodynamics of the company’s lead drug candidate Orviglance. Preliminary results show that Orviglance was well tolerated in patients with liver impairment. The study is part of the ...

ByAscelia Pharma AB


Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes

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 ...

ByBayer AG

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