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End Stage Renal Disease Articles & Analysis: Older

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 complications and ...

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

The study demonstrated that finerenone reduced the risk of cardiovascular events in a broad population of patients with stages 1-4 CKD and T2D. The CHMP recommended the approval of the extension of the indication of Kerendia™ (10 mg or 20 mg) to early stages* of CKD associated with T2D: “Kerendia is indicated for the treatment of chronic kidney ...

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. ...

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 CV and ...

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

“Patients need to be screened regularly and treated early to prevent them from progressing to more advanced stages of chronic kidney disease, as this may lead to better outcomes for these patients, potentially preventing cardiovascular complications and death,” said Dr. ...

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 kidney ...

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

Approximately half of patients with high-level BK viremia develop BKV nephropathy (BKVN), which can lead to decreased kidney survival and a return to end-stage renal disease and dialysis. There are no approved or effective antiviral treatments for BK viremia. ...

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

(“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. ...

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

” “This is an exciting time for the renal transplant community and more broadly for medicine. The hope is that CAR-Treg cell therapies reduce the need for lifelong immunosuppressive medications, which are known to have challenging side effects,” said Dr. ...

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

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


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 are below 20%. ...

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 virus-specific T cell ...

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

About Cara Therapeutics Cara Therapeutics is an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. ...

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


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). ESKD occurred in 0.9% of finerenone versus 1.3% placebo recipients (HR=0.64; 95% CI 0.41-0.995; p=0.046). ...

ByBayer AG


Outset Medical Launches Inaugural ESG Report

Outset Medical Launches Inaugural ESG Report

Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced the release of its inaugural Environmental, Social, and Governance (ESG) report highlighting its ESG-related programs, priorities, goals, and performance. “At Outset, our ESG journey is rooted in our ...

ByOutset Medical

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