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End Stage Kidney Disease Articles & Analysis

33 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

“Despite progress in risk reduction in type 2 diabetes, chronic kidney disease in type 1 diabetes remains understudied, leaving a huge unmet need to reduce the risks of end-stage kidney disease and cardiovascular events. ...

ByBayer AG


Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes

Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes

“As chronic kidney disease progresses silently, with oftentimes no symptoms in the early stages, patients with type 2 diabetes should be regularly monitored by their doctor for the earliest signs of kidney disease, and once diagnosed should be treated comprehensively to reduce the risk of cardiovascular ...

ByBayer AG


Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes

Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes

“FIGARO-DKD is the first contemporary Phase III cardiovascular outcomes trial to show cardiovascular benefit in patients with chronic kidney disease and type 2 diabetes where the majority of the population were in earlier stages* with ...

ByBayer AG


Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

(“Inversago”), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD). ...

ByInversago Pharma


Stanford Surgeon Venita Chandra Joins Alucent Biomedical Scientific Advisory Board as Company Enters Arteriovenous Fistula Market

Stanford Surgeon Venita Chandra Joins Alucent Biomedical Scientific Advisory Board as Company Enters Arteriovenous Fistula Market

The prevalence of end-stage renal disease continues to rise, and there is a growing need for HD. The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines and the Fistula First Breakthrough Initiative recommend AVFs as the preferred type of vascular access ...

ByAlucent Biomedical 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

FIDELITY investigated the efficacy and safety of Kerendia across a broad range of patients with early to late-stage CKD and T2D and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes – KDIGO – risk categories) and the effects of Kerendia on composite ...

ByBayer AG


Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study

Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study

FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal myocardial infarction (MI), and hospitalization for heart failure in adult patients with CKD associated with T2D. ...

ByBayer AG


Kerendia (finerenone) approved in China for the treatment of adults with chronic kidney disease associated with type 2 diabetes

Kerendia (finerenone) approved in China for the treatment of adults with chronic kidney disease associated with type 2 diabetes

Kerendia™ (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is indicated for the treatment of chronic kidney disease (CKD) (eGFR of ≥ 25 to 75 mL/min/1.73 m2 with albuminuria) associated with type 2 diabetes (T2D) in adults, to reduce the risk of sustained eGFR decline and end-stage ...

ByBayer AG


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

(Nasdaq: ALVR), a late-clinical stage allogeneic T-cell immunotherapy company, today announced preliminary, blinded data from an ongoing Phase 2 study of posoleucel, an investigational, allogeneic, off-the-shelf, multi-virus-specific T cell (VST) therapy, for the treatment of BK viremia (BKV) in adult kidney transplant recipients. ...

ByKalaris


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

Improvements in kidney size, function, and renal matrix remodeling, with corresponding gene expression were noted with both doses of 0.3 mg/kg and 3 mg/kg of INV-202”, said Dr. ...

ByInversago Pharma


Sangamo Therapeutics Announces Dosing of First Patient in Phase 1/2 Clinical Study of Investigational CAR-Treg Cell Therapy TX200 in Kidney Transplantation

Sangamo Therapeutics Announces Dosing of First Patient in Phase 1/2 Clinical Study of Investigational CAR-Treg Cell Therapy TX200 in Kidney Transplantation

“I look forward to the dosing of more patients and seeing data from the study to understand the potential of TX200.” Kidney transplantation is the treatment of choice for patients with end-stage renal disease (ESRD) who must otherwise remain on long-term dialysis. Approximately 21-26% of transplanted ...

BySangamo Therapeutics


Bayer receives approval in Japan for Kerendia (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes

Bayer receives approval in Japan for Kerendia (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes

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


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

The secondary efficacy endpoint is time to composite clinical outcome, which will also be assessed at the final analysis and is defined as a sustained decline of ≥30% from baseline in eGFR, the onset of end-stage kidney disease (i.e., maintenance dialysis for ≥28 days, kidney transplantation or a sustained ...

ByVertex Pharmaceuticals


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

“As most patients have no symptoms in the early stages, people with type 2 diabetes should regularly be monitored by their doctor for the earliest signs of kidney disease. ...

ByBayer AG


CloudCath Announces $12 Million Series A Financing for Technology Enabling Remote, Real-Time Complication Monitoring for At-Home Dialysis

CloudCath Announces $12 Million Series A Financing for Technology Enabling Remote, Real-Time Complication Monitoring for At-Home Dialysis

A July 2019 White House executive order on kidney care (the Advancing American Kidney Health Initiative) proposed that 80% of new patients with end-stage renal disease (ESRD) be treated with either kidney transplantation or home dialysis by 2025, a significant increase from current rates, which ...

ByCloudCath


AlloVir Reports Full-Year 2021 Financial Results and 2022 Outlook

AlloVir Reports Full-Year 2021 Financial Results and 2022 Outlook

Three ongoing Phase 3 registrational studies of posoleucel expected in 2022, targeting treatment and prevention indications with no approved therapies Expanded enrollment in Phase 2 proof-of-concept study of posoleucel for the preemptive treatment of BK viremia in kidney transplant recipients; initial data submitted for presentation in 1H 2022 Advancing two additional ...

ByKalaris


Cara Therapeutics Announces Difelikefalin (KORSUVA) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients

Cara Therapeutics Announces Difelikefalin (KORSUVA) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients

The company’s novel KORSUVA™ (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The company is developing an oral KORSUVA (difelikefalin) formulation and plans to initiate Phase 3 programs in the first quarter of 2022 for the ...

ByCara Therapeutics.


Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes

Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes

Finerenone (10 mg or 20 mg) is recommended for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. ...

ByBayer AG


Outset Medical Launches Inaugural ESG Report

Outset Medical Launches Inaugural ESG Report

” Notable ESG achievements during Outset’s first year as a public company include: Raising awareness of patient disparities in kidney care Advocating for progressive, patient-centric policies to improve the lives of dialysis patients has been, and continues to be, a key area of focus for Outset, particularly as COVID-19’s disparate impact on people of ...

ByOutset Medical


New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy

New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy

The effect of finerenone on the composite kidney outcomes was reflected by a 36% relative risk reduction of end-stage kidney disease (ESKD). ...

ByBayer AG

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