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DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX), a global innovator in renal care, has launched a new version of its AK 98 hemodialysis (HD) system offering two-way IT connectivity, capabilities to meet the needs of patients with lower weights, and functions that simplify treatment set up and reduce downtime between sessions. The AK 98 system can be used to deliver HDx enabled by THERANOVA, Baxter’s latest hemodialysis therapy that provides high performance treatments with integration into existing healthcare infrastructure. Due to kidney failure, people with end-stage renal disease retain harmful toxins in their blood. During HD therapy, blood is passed through a dialyzer, which acts as the artificial kidney to filter toxins from the blood. “ We designed our new AK 98 system specifically to help dialysis providers minimize the operational challenges associated with hemodialysis,” said Laura Angelini, general manager, Chronic Renal at Baxter. “ Enhanced features such as two-way IT connectivity and an easy-to-use interface were designed to eliminate time spent manually handling documents and improve clinical workflows.” The AK 98 system can now be connected to the dialysis provider’s central IT network, allowing seamless management and integration of clinic and treatment information. During treatment set-up, the hemodialysis prescription is sent to the AK 98 system from the provider’s central IT network. Once treatment is concluded, the encrypted data is transmitted back to the provider’s network, where it is secured and stored. Treatment data is then cleared from the AK 98 system. The AK 98 system features new blood lines, which work alongside Baxter’s smallest dialyzers, to help providers treat low weight patients, whose lower blood volumes require specialized equipment for effective HD treatment. The AK 98 system, which first launched in 2015, is available in many countries in Asia, Europe and Latin America. It is not currently available for use in the United States. More information is available at ak98system.com. Baxter’s HDx therapy, or expanded hemodialysis, is enabled by the THERANOVA dialyzer, an innovative membrane that provides the opportunity for HDF performance and beyond. HDx enabled by THERANOVA effectively targets large middle molecules not efficiently removed by currently available dialysis treatments. In a study published in Nephrology Dialysis Transplantation1, researchers found that the THERANOVA dialyzer removes a wide range of middle molecules more effectively than FX CorDiax high-flux dialyzer, and can exceed the performance of high-volume HDF for large solutes, with moderate albumin removal.1 THERANOVA dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. HDx enabled by THERANOVA therapy is available in Europe, Australia, and New Zealand. It is not available for use in the United States. More information is available at hdxtheranova.com. Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. This release includes forward-looking statements concerning the AK 98 system and the THERANOVA dialyzer, including potential benefits associated with their use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; breaches or failures of the company’s information technology systems; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements. Baxter, AK 98 and Theranova are trademarks of Baxter International Inc. or its subsidiaries. Cordiax is a trademark of Fresenius Medical Care Deutschland GmbH 1 Kirsch A. H., et al. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant (2016) September 1 Advance Access.


Urea-Torres P.,Nephrology Dialysis | Metzger M.,French Institute of Health and Medical Research | Metzger M.,University Paris - Sud | Haymann J.P.,Hopital Tenon | And 20 more authors.
American Journal of Kidney Diseases | Year: 2011

Background: Vitamin D (25 hydroxyvitamin D [25(OH)D]) deficiency is common in patients with chronic kidney disease (CKD). Neither the relation of this deficiency to the decrease in glomerular filtration rate (GFR) nor the effects on CKD mineral and bone disorders (MBD) are clearly established. Study Design: Cross-sectional analysis of baseline data from a prospective cohort, the NephroTest Study. Setting & Participants: 1,026 adult patients with all-stage CKD not on dialysis therapy or receiving vitamin D supplementation. Predictors: For part 1, measured GFR (mGFR) using 51Cr-EDTA renal clearance; for part 2, 25(OH)D deficiency at <15 ng/mL. Outcomes & Measurements: For part 1, 25(OH)D deficiency and several circulating MBD markers; for part 2, circulating MBD markers. Results: For part 1, the prevalence of 25(OH)D deficiency was associated inversely with mGFR, ranging from 28%-51% for mGFR <60-<15 mL/min/1.73 m 2. It was higher in patients of African origin; those with obesity, diabetes, hypertension, macroalbuminuria, and hypoalbuminemia; and during winter. After adjusting for these factors, ORs for 25(OH)D deficiency increased from 1.4 (95% CI, 0.9-2.3) to 1.4 (95% CI, 0.9-2.1), 1.7 (95% CI, 1.1-2.7), and 1.9 (95% CI, 1.1-3.6) as mGFR decreased from 45-59 to 30-44, 15-29, and <15 (reference, <60) mL/min/1.73 m 2 (P for trend = 0.02). For part 2, 25(OH)D deficiency was associated with higher age-, sex-, and mGFR-adjusted ORs of ionized calcium level <1.10 mmol/L (2.6; 95% CI, 1.2-5.9), 1,25 dihydroxyvitamin D concentration <16.7 pg/mL (1.8; 95% CI, 1.3-2.4), hyperparathyroidism (1.8; 95% CI, 1.3-2.4), and serum C-terminal cross-linked collagen type I telopeptides concentration >1,000 pg/mL (1.6; 95% CI, 1.0-2.6). It was not associated with hyperphosphatemia (phosphate >1.38 mmol/L). Limitations: Cross-sectional analysis of the data prevents causal inferences. Conclusions: 25(OH)D deficiency is related independently to impaired mGFR. Both mGFR decrease and 25(OH)D deficiency are associated with abnormal levels of circulating MBD biomarkers. © 2011 National Kidney Foundation, Inc.


PubMed | Louisiana State University in Shreveport, University of Mississippi Medical Center, Orvos es Egeszsegtudomanyi Centrum, Nephrology Dialysis and Semmelweis University
Type: | Journal: Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis | Year: 2016

Background: Hypokalemia is a vexing problem in end-stage renal disease patients on peritoneal dialysis (PD), and oral potassium supplements (OPS) have limited palatability. Potassium-sparing diuretics (KSD) (spironolactone, amiloride) may be effective in these patients. Methods: We performed a cross-sectional review of 75 current or past (vintage > 6 months) PD patients with regard to serum potassium (K


PubMed | Nephrology Dialysis
Type: Journal Article | Journal: Kidney international | Year: 2012

Renal function impairment goes along with a disturbed calcium, phosphate, and vitamin D metabolism, resulting in secondary hyperparathyroidism (sHPT). These mineral metabolism disturbances are associated with soft tissue calcifications, particularly arteries, cardiac valves, and myocardium, ultimately associated with increased risk of mortality in patients with chronic kidney disease (CKD). sHPT may lead to cardiovascular calcifications by other mechanisms including an impaired effect of parathyroid hormone (PTH), and a decreased calcium-sensing receptor (CaR) expression on cardiovascular structures. PTH may play a direct role on vascular calcifications through activation of a receptor, the type-1 PTH/PTHrP receptor, normally attributed to PTH-related peptide (PTHrP). The CaR in vascular cells may also play a role on vascular mineralization as suggested by its extremely reduced expression in atherosclerotic calcified human arteries. Calcimimetic compounds increasing the CaR sensitivity to extracellular calcium efficiently reduce serum PTH, calcium, and phosphate in dialysis patients with sHPT. They upregulate the CaR in vascular cells and attenuate vascular mineralization in uremic states. In this article, the pathophysiological mechanisms associated with cardiovascular calcifications in case of sHPT, the impact of medical and surgical correction of sHPT, the biology of the CaR in vascular structures and its function in CKD state, and finally the role played by the CaR and its modulation by the calcimimetics on uremic-related cardiovascular calcifications are reviewed.


PubMed | Nephrology Dialysis
Type: Journal Article | Journal: American journal of kidney diseases : the official journal of the National Kidney Foundation | Year: 2011

Vitamin D (25 hydroxyvitamin D [25(OH)D]) deficiency is common in patients with chronic kidney disease (CKD). Neither the relation of this deficiency to the decrease in glomerular filtration rate (GFR) nor the effects on CKD mineral and bone disorders (MBD) are clearly established.Cross-sectional analysis of baseline data from a prospective cohort, the NephroTest Study.1,026 adult patients with all-stage CKD not on dialysis therapy or receiving vitamin D supplementation.For part 1, measured GFR (mGFR) using (51)Cr-EDTA renal clearance; for part 2, 25(OH)D deficiency at <15 ng/mL.For part 1, 25(OH)D deficiency and several circulating MBD markers; for part 2, circulating MBD markers.For part 1, the prevalence of 25(OH)D deficiency was associated inversely with mGFR, ranging from 28%-51% for mGFR 60-<15 mL/min/1.73 m(2). It was higher in patients of African origin; those with obesity, diabetes, hypertension, macroalbuminuria, and hypoalbuminemia; and during winter. After adjusting for these factors, ORs for 25(OH)D deficiency increased from 1.4 (95% CI, 0.9-2.3) to 1.4 (95% CI, 0.9-2.1), 1.7 (95% CI, 1.1-2.7), and 1.9 (95% CI, 1.1-3.6) as mGFR decreased from 45-59 to 30-44, 15-29, and <15 (reference, 60) mL/min/1.73 m(2) (P for trend = 0.02). For part 2, 25(OH)D deficiency was associated with higher age-, sex-, and mGFR-adjusted ORs of ionized calcium level <1.10 mmol/L (2.6; 95% CI, 1.2-5.9), 1,25 dihydroxyvitamin D concentration <16.7 pg/mL (1.8; 95% CI, 1.3-2.4), hyperparathyroidism (1.8; 95% CI, 1.3-2.4), and serum C-terminal cross-linked collagen type I telopeptides concentration >1,000 pg/mL (1.6; 95% CI, 1.0-2.6). It was not associated with hyperphosphatemia (phosphate >1.38 mmol/L).Cross-sectional analysis of the data prevents causal inferences.25(OH)D deficiency is related independently to impaired mGFR. Both mGFR decrease and 25(OH)D deficiency are associated with abnormal levels of circulating MBD biomarkers.

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