Renal physiology

Trevena Announces First Patient Enrolled in NIH-Funded ACTIV-4 Host Tissue Trial of TRV027 for COVID-19

Retrieved on: 
Monday, July 26, 2021

I am excited that patients are now being enrolled in this study and that TRV027 is the one of the first active treatment arms available for patient randomization.

Key Points: 
  • I am excited that patients are now being enrolled in this study and that TRV027 is the one of the first active treatment arms available for patient randomization.
  • The trial, known as ACTIV-4 Host Tissue, is testing four investigational agents that combat dysregulation of the renin-angiotensin-aldosterone system (RAAS) and the immune system caused by a COVID-19 infection.
  • The trial is enrolling approximately 1,600 patients at over 50 sites in the U.S. TRV027 is part of the initial trial launch, and additional study arms will be added to the trial over time.
  • I am very pleased that we have enrolled our first patient in the ACTIV-4 Host Tissue trial, and I look forward to investigating the potential of TRV027 to modulate the RAAS and improve outcomes for patients hospitalized with COVID-19.

American Medical Association Issues New CPT Code for Nuwellis’ Aquadex Ultrafiltration

Retrieved on: 
Tuesday, July 13, 2021

The new CPT code will come into effect on January 1, 2022, at which time providers can utilize the code when using Aquadex to deliver ultrafiltration to adults and children (20 kg or more).

Key Points: 
  • The new CPT code will come into effect on January 1, 2022, at which time providers can utilize the code when using Aquadex to deliver ultrafiltration to adults and children (20 kg or more).
  • A specific code for ultrafiltration was granted after a thorough review and validation that the technology met the criteria for a Category III CPT code.
  • The approved Therapeutic Ultrafiltration Category III CPT code will be in effect for at least five years.
  • We are confident the Category III CPT code will enable patient access through adoption by providers who prescribe ultrafiltration for their fluid-overloaded patients.

Nuwellis Inc. to Participate at the 2021 Ladenburg Thalmann Healthcare Conference

Retrieved on: 
Tuesday, July 6, 2021

An audio webcast of the presentation will be available online at the Nuwellis investor relations website,https://ir.nuwellis.com.

Key Points: 
  • An audio webcast of the presentation will be available online at the Nuwellis investor relations website,https://ir.nuwellis.com.
  • Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation.
  • The company is focused on developing, manufacturing, and commercializing the Aquadex SmartFlow system for ultrafiltration therapy.
  • Nuwellis is a Delaware corporation headquartered in Minneapolis, Minnesota with a wholly owned subsidiary in Ireland.

Nationwide Access to Ultrafiltration Therapy Possible with Nuwellis and Premier, Inc. Collaboration

Retrieved on: 
Tuesday, June 1, 2021

The collaboration provides Nuwellis with the opportunity to expand into many of the thousands of hospitals with which Premier holds relationships.

Key Points: 
  • The collaboration provides Nuwellis with the opportunity to expand into many of the thousands of hospitals with which Premier holds relationships.
  • The immense value of this collaboration will be felt by hospitals dedicated to offering its patients with the most innovative technology.
  • The Company prioritizes collaboration and innovation to provide unsurpassed care to pediatric, critical care and heart failure patients.
  • The Company is focused on developing, manufacturing and commercializing the Aquadex SmartFlow System for ultrafiltration therapy.

Aurinia To Present Supportive AURORA 2 Continuation Study Interim Analysis Demonstrating Long-Term Safety & Efficacy of LUPKYNIS™ (voclosporin) in Subjects with Lupus Nephritis

Retrieved on: 
Thursday, May 20, 2021

The interim analysis to be presented at EULAR evaluated subjects with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2.

Key Points: 
  • The interim analysis to be presented at EULAR evaluated subjects with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2.
  • Data from 124 subjects (73 voclosporin; 51 control arm) who had received 104 weeks of continuous treatment was analyzed.
  • A greater reduction in proteinuria between arms was also observed between 1 and 2 years (1.0 vs 0.6 mg/mg; voclosporin vs control).
  • Renal function as determined by eGFR remained stable over 104 weeks in both groups compared to baseline assessments.

ACC 2021 Presentation Adds to Body of Evidence Supporting Nuwellis Ultrafiltration to Treat Patients with Heart Failure

Retrieved on: 
Monday, May 17, 2021

The single-center study evaluated 30 ADHF patients in mainstream setting (i.e., step-down unit, not critical care) who were treated with Aquadex therapy.

Key Points: 
  • The single-center study evaluated 30 ADHF patients in mainstream setting (i.e., step-down unit, not critical care) who were treated with Aquadex therapy.
  • Aquadex achieved gratifying symptom improvement by fluid removal without worsening renal function, and reduced heart failure readmission rates in this cohort of our most challenging patients.
  • \xe2\x80\x9cOur gentle ultrafiltration therapy is built to effectively remove fluid at a customizable rate, which is beneficial for fragile patients such as those with heart failure.
  • Presented at: Heart Failure Society of America Scientific Meeting; Sept. 30-Oct. 6, 2020 (virtual meeting).\nPresident, Chief Executive Officer and Chief Financial Officer, Nuwellis, Inc.\n'

Global Moderate and Severe Chronic Kidney Disease Pipeline Insight Report 2021 Featuring KBP-5074: KBP Biosciences & ELIXCYTE: UnicoCell Biomed - ResearchAndMarkets.com

Retrieved on: 
Thursday, May 13, 2021

b'The "Moderate and Severe Chronic Kidney Disease - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com\'s offering.\nThis "Moderate and Severe Chronic Kidney Disease - Pipeline Insight, 2021," report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in Moderate and Severe Chronic Kidney Disease pipeline landscape.\nIt covers the pipeline drug profiles, including clinical and nonclinical stage products.

Key Points: 
  • b'The "Moderate and Severe Chronic Kidney Disease - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com\'s offering.\nThis "Moderate and Severe Chronic Kidney Disease - Pipeline Insight, 2021," report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in Moderate and Severe Chronic Kidney Disease pipeline landscape.\nIt covers the pipeline drug profiles, including clinical and nonclinical stage products.
  • It further highlights the inactive pipeline products in this space.\nThe companies and academics are working to assess challenges and seek opportunities that could influence Moderate and Severe Chronic Kidney Disease R&D.
  • For chronic kidney disease (CKD) treatment (NCT02933827), the phase-II clinical trial is ongoing.\nModerate and Severe Chronic Kidney Disease: Therapeutic Assessment\nThis segment of the report provides insights about the different Moderate and Severe Chronic Kidney Disease drugs segregated based on following parameters that define the scope of the report, such as:\nThere are approx.
  • phase II include, KBP Bioscience.\nModerate and Severe Chronic Kidney Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Nuwellis Provides More Children in Texas With Access to Its Unique Fluid Management Technology

Retrieved on: 
Thursday, May 13, 2021

This is particularly important for pediatric patients, who have a small amount of blood in their bodies.

Key Points: 
  • This is particularly important for pediatric patients, who have a small amount of blood in their bodies.
  • Aquadex is clinically proven1 to be safe and effective in children weighing 20 kg or more.
  • \xe2\x80\x9cHaving the flexibility to customize therapy for each unique patient is especially advantageous in smaller pediatric patients who have a smaller margin of error.
  • The Company is focused on developing, manufacturing and commercializing the Aquadex SmartFlow\xc2\xae System for ultrafiltration therapy.

AACC Releases Guidance on Improving Care for Acute Kidney Injury With Clinical Laboratory Tests

Retrieved on: 
Tuesday, May 11, 2021

It is therefore essential that clinical laboratory professionals and clinicians know what the right tools are for diagnosing AKI.

Key Points: 
  • It is therefore essential that clinical laboratory professionals and clinicians know what the right tools are for diagnosing AKI.
  • However, current approaches to detecting this condition differ widely throughout the medical community due to factors such as inconsistent integration of new findings on AKI into clinical practice.
  • To remedy this, AACC\'s guidance proposes using new diagnostic thresholds, known as the 20/20 AACC AKI criteria, to determine whether a patient has AKI with creatinine testing.
  • Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation.

Removing Race from Estimates of Kidney Function: What Happens Next?

Retrieved on: 
Friday, April 9, 2021

Last month, ASN and NKF asserted that race modifiers should not be included in equations used to estimate kidney function.

Key Points: 
  • Last month, ASN and NKF asserted that race modifiers should not be included in equations used to estimate kidney function.
  • In its final report, the task force will recommend the best approach to replace the existing equations for estimating kidney function.
  • Both the interim and final reports will guide the kidney community in developing an evidence-based guideline for practice.
  • The NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Diseases welcomes your input to the Interim Report.