Optiflux Dialyzers Show Mean Increase of Serum Albumin in Hemodialysis Patients

WALTHAM, Mass., March 26, 2020 /PRNewswire/ -- Hemodialysis patients treated with Optiflux® high flux single-use dialyzers experienced a mean increase in serum albumin levels, according to results from a recent clinical trial and separate retrospective analysis conducted by Fresenius Medical Care North America. The results are included in two abstracts presented virtually this week as part of the National Kidney Foundation (NKF) 2020 Spring Clinical Meetings.

The preservation of albumin is important because a low level of albumin, known as hypoalbuminemia, has been previously associated with increased morbidity and mortality in patients on maintenance hemodialysis (HD).^1,2 Optiflux high-flux dialyzers are designed to enhance small and middle molecule clearance without increasing albumin loss.³

The first abstract, Clinical Performance Of The Optiflux® F160NR Dialyzer, examines the results from a recent clinical trial that included a period of four weeks during which patients were using the F160NR Optiflux dialyzer. Within a single HD session in 23 patients, mean (SD) serum albumin increased from a pre-HD value of 3.97g/dL (0.31) to 4.29 g/dL (0.4) post-HD over the course of an HD session.

In the second abstract, Evaluation of Biomarkers in Chronic Hemodialysis (HD) Patients Dialyzed with Optiflux High-flux Dialyzers, 976 in-center incident HD patients treated exclusively with Optiflux high-flux dialyzers for 6 months were analyzed as part of a retrospective analysis and showed a moderate, but statistically significant increase in serum albumin and a significant increase in hemoglobin, while maintaining dialysis adequacy. 

Within a sub-group of 156 patients with hypoalbuminemia at the start of the study, 87 percent of these patients had increases in serum albumin by the sixth month regardless of the Optiflux model (48/59 or 81.4 percent in F160NR, 82/92 or 89.1 percent in F180NR, and 5/5 or 100 percent in F200NR and F250NR). Overall, the mean increase in serum albumin was 0.31 g/dL in the hypoalbuminemia subgroup.

"The results described in these abstracts are further indication of the benefit Optiflux dialyzers provide with regards to preserving serum albumin levels in patients on maintenance hemodialysis," said Dr. Michael Anger, Chief Medical Officer for Renal Therapies Group at Fresenius Medical Care North America. "This is important, as many studies have demonstrated the potential dangers of low serum albumin levels, especially when patients have hypoalbuminemia at the start of hemodialysis."

For more information about Optiflux high flux single-use dialyzers, please visit here.

¹Owen et al, NEJM, 1993. The urea reduction ratio and serum albumin concentration as predictors of mortality in patients undergoing hemodialysis.  
² Lowrie and Lew, AJKD, 1990. Death Risk in Hemodialysis Patients: The Predictive Value of Commonly Measured Variables and an Evaluation of Death Rate Differences Between Facilities. 
³ Krieter et al, Artif Organs, 2008. A new synthetic dialyzer with advanced permselectivity for enhanced low-molecular weight protein removal.

INDICATIONS FOR USE:
Optiflux F160NRe, F180NRe, F200NRe and F250NRe dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Optiflux F160NRe, F18NRe, and F180NR, and Hemoflow F3 and F4 dialyzers are designed for single use in acute and chronic hemodialysis. The Hemoflow F40S is designed for single use in chronic hemodialysis or hemodiafiltration. The applicability of a dialyzer for a particular treatment is the responsibility of the physician.

Caution: Federal (US) law restricts these devices to sale by or on order of a physician.

Note: Read the Instructions for Use for safe and proper use of these devices. For a complete description of hazards, contraindications, side effects and precautions, see full package labeling at fmcna.com. In rare cases, thrombocytopenia or hypersensitivity reactions including anaphylactic or anaphylactoid reactions to the dialyzer, or other elements in the extracorporeal circuit may occur during hemodialysis.

About Fresenius Medical Care North America
Fresenius Medical Care North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities, outpatient cardiac and vascular labs and urgent care centers, Fresenius Medical Care North America provides coordinated health care services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world's largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com/.

Media Contact:

Fresenius Medical Care North America
Brad Puffer
Corporate Communications
brad.puffer@fmc-na.com 
(781) 699-3331

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SOURCE Fresenius Medical Care Holdings, Inc.