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Citrasate® is an acid concentrate for bicarbonate-based dialysis that uses citric acid, a known anticoagulant, instead of acetic acid as the primary acidifying agent.  Citrasate® is an acid concentrate for bicarbonate-based dialysis that uses citric acid, a known anticoagulant, instead of acetic acid as the primary acidifying agent. 

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  hemodialysis News and hemodialysis Current Topics
NEWS: Hemodialysis - Dialysis - ESRD - CKD News & Research Interviews
Depressive symptoms associate with high mortality risk & dialysis withdrawal in incident hemodialysis patients:
Dr. Lacson
Nephrology Dialysis Transplant
Global Trends in Rates of Peritoneal Dialysis: Dr. Jain JASN
Structural Equation Modeling Highlights the Potential of Kim-1 as CKD Biomarker: Dr. Gardiner Am J Nephrology
Protective effects of PPARγ agonist in acute nephrotic syndrome: Dr. Fogo Nephrology Dialysis Transplant
A Computerized Treatment Algorithm Trial to Optimize Mineral Metabolism in ESRD: Dr. Spiegel CJASN
Development/Validation of Expedited 10g Protein Counter for Dietary Protein Intake : SL Lim J.Renal Nutrition
IL-6-independent risk factor for ESAs resistance in hemodialysis pts without iron deficiency: Dr. Kim Hemodialysis Int'l
Troponin I & Postoperative Myocardial Infarction after Renal Transplantation : Dr. Shroff Amer J Nephrology
Longitudinal Progression Trajectory of GFR in CKD: Dr. Li : AJ Kidney Disease

CINACALCET (SENSIPAR) Calcimimetic Agents in CKD | ESRD | Dialysis and Hemodialysis Patients

Patients with chronic kidney disease have special issues in regulating mineral metabolism.
The kidneys actively hold onto necessary minerals and excrete or get rid of minerals thought to be in excessive supply. Some of these minerals necessary for cellular functions include sodium, potassium, calcium and phosphorous.

The kidneys play a unique role in calcium regulation due to the fact that healthy kidneys activate a form of Vitamin D. Vitamin D in turn facilitates absorption of Calcium from the intestines from the food or from bones.

Other important glands in this metabolic system are the parathyroids. These small glands in the neck secrete a hormone called PTH or parathyroid hormone that boosts the absorption of calcium from the intestine or bones if the body is deemed to have too little calcium.

Patients with abnormal, or scarred kidneys do not make sufficient active Vitamin D. Chronic kidney disease (CKD) patients or end stage renal disease (ESRD) patients therefore may be deficient in calcium and have an elevated parathyroid level. This elevated PTH level is called secondary hyperparathyrodism.

There are several methods of helping to control mineral metabolism in ESRD and CKD patients. Some of these methods include diet, Vitamin D supplementation and drugs which help absorb excessive minerals from the intestine. A relatively new medication acts to help decrease parathyroid hormone production by making the parathyroid gland more sensitive to calcium. This new class of medication is called a calcimimetic because it mimics the effects of calcium on the parathyroid glands.

The articles reference below discuss calcimemetics in CKD and ESRD.

Author Interview: David M. Spiegel, MD, FACP

A Computerized Treatment Algorithm Trial to Optimize Mineral Metabolism in ESRD

David M. Spiegel, Lesley McPhatter, Ann Allison, Joanne C. Drumheller, and Robert Lockridge

CJASN CJN.08170811; published ahead of print February 2012 doi:10.2215/CJN.08170811

Author Interview: Ryota Ikee, MD
Potential influence of sevelamer hydrochloride on responsiveness to erythropoiesis-stimulating agents in haemodialysis patients.

Ikee R, Tsunoda M, Sasaki N, Sato N, Hashimoto N.

Nephrology (Carlton). 2011 Nov 24.
doi: 10.1111/j.1440-1797.2011.01545.x.

Author Interview: Charles M. Henley

Cinacalcet HCl prevents development of parathyroid gland hyperplasia and reverses established parathyroid gland hyperplasia in a rodent model of CKD


Gerald Miller, James Davis, Edward Shatzen, Matthew Colloton, David Martin, and Charles M. Henley
Department of Metabolic Disorders, Amgen Inc., Thousand Oaks, CA, USA
Nephrol. Dial. Transplant.
first published online October 29, 2011 doi:10.1093/ndt/gfr589


Author Interview:
J. Andrew Lee, PhD, ScM
A Study of the Association between Cinacalcet Adherence and Biochemical Outcomes


Abstract: [TH-PO263]

Andrew Lee, PhD, Vasily Belozeroff, PhD, Richard Mutell, T. Christopher Bond, PhD, William G. Goodman, MD. Amgen Inc; DaVita Clinical Research.

Author Interview: Dr. Jesús Montenegro

Efficacy and safety of cinacalcet for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney disease before initiation of regular dialysis.

Montenegro J, Cornago I, Gallardo I, García-Ledesma P, Hernando A, Martinez I, Muñoz RI, Romero MA.
Servicio de Nefrología, Hospital de Galdakao-Usansolo, Galdakao, Vizcaya, Spain.
Nephrology (Carlton). 2011 Oct 25. doi: 10.1111/j.1440-1797.2011.01530.x.

Author Interview: Dr. Giuseppe Cianciolo

VDR Expression on Circulating Endothelial Progenitor Cells in Dialysis Patients Is Modulated by 25(OH)D Serum Levels and Calcitriol Therapy.
Cianciolo G, La Manna G, Cappuccilli ML, Lanci N, Della Bella E, Cuna V, Dormi A, Todeschini P, Donati G, Alviano F, Costa R, Bagnara GP, Stefoni S.
Nephrology Dialysis and Renal Transplantation Unit, S. Orsola University Hospital, Bologna, Italy.
Blood Purif. 2011 Jul 9;32(3):161-173.

Author Interview: Dr. Christopher Chan, MD

Improved parathyroid hormone control by cinacalcet is associated with reduction in darbepoetin requirement in patients with end-stage renal disease.

Battistella M, Richardson RM, Bargman JM, Chan CT.
Division of Nephrology, Department of Medicine, University Health Network, Toronto, ON, Canada.
Clin Nephrol. 2011 Aug;76(2):99-103.

Sensipar(R) Patents Upheld By District Court
Injunction Prohibits Teva and Barr from Marketing Generic Versions of Amgen's Sensipar Through 2018 Patent Expiry

THOUSAND OAKS, Calif., Jan. 7, 2011

A U.S. District Court in Delaware today granted an injunction preventing Teva Pharmaceuticals USA, Inc., Teva Pharmaceuticals Industries Ltd., and Barr Laboratories, Inc. from commercializing generic versions of Amgen's (Nasdaq: AMGN) Sensipar(R) (cinacalcet) until expiration of the drug's U.S. patents. The latest Sensipar expiry is in 2018. Sensipar is approved for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis and for the treatment of elevated levels of calcium in patients with parathyroid carcinoma.

Comparative Effectiveness of Paricalcitol versus Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis.

Nephron Clin Pract. 2010 Aug 10;117(2):c151-c159.

Schumock GT, et al
Center for Pharmacoeconomic Research, Department of Pharmacy Practice, and Department of Pharmacy Administration, University of Illinois at Chicago, Chicago, Ill.

Calcimimetic Agents in CKD ESRD Dialysis and Hemodialysis Patients

CINACALCET (SENSIPAR) USE INTO A PARICALCITOL (ZEMPLAR) PROTOCOL IN SECONDARY HYPERPARATHYROIDISM
Barbara Clark, Bruno Lima, Piyush Lohiya, Dept of Nephrology,
Allegheny General Hospital, Pittsburgh, PA, USA 
Abstract presented at the National Kidney Foundation Spring Clinical Meeting 2010

Sensipar (Cinacalcet) is made by Amgen. The Sensipar website has a number of educational resource, including prescribing and safety information.

Cinacalcet Decreases Bone Formation Rate in Hypercalcemic Hyperparathyroidism after Kidney Transplantation.

Am J Nephrol. 2010 Apr 30;31(6):482-489.
Borchhardt KA, Diarra D, Sulzbacher I, Benesch T, Haas M, Sunder-Plassmann G.
Division of Nephrology and Dialysis, Department of Medicine III, Medical University Vienna, Vienna, Austria.

Abstract: Hypercalcemia secondary to persistent hyperparathyroidism in kidney transplant patients: analysis after a year with cinacalcet.

J Nephrology. 2010 May 2. pii: 8E39C3E1-CF8D-4F2A-94D3-D72F4B99DFFC.
Guerra R, Auyanet I, Fernández EJ, Pérez MA, Bosch E, Ramírez A, Suria S, Checa MD.
Department of Nephrology, Hospital Insular de Gran Canaria, Las Palmas de Gran Canaria - Spain.

Calcimimetic inhibits late-stage cyst growth in ADPKD.

Journal of the American Society of Nephrology. 2009 Jul;20(7):1527-32.
Gattone VH 2nd, Chen NX, Sinders RM, Seifert MF, Duan D, Martin D, Henley C, Moe SM.
Department of Anatomy and Cell Biology, Indiana University School of Medicine, 635 Barnhill Drive, Indianapolis, Indiana 46202, USA. vgattone@iupui.edu
Comment in:

  • J Am Soc Nephrol. 2009 Jul;20(7):1421-5.

 

 

 

 

 

 
Author Interviews: hemodialysis - Dialysis - ESRD - CKD
Predictors of eGFR Decline in Type 2 Diabetes & Preserved Kidney Function: Dr. Chonchol CJASN
Tenecteplase for improvement of blood flow in dysfunctional hemodialysis catheters: Dr. Goldman Clin Neph
Religious coping, psychological distress and quality of life in hemodialysis: Dr. Carvalho J Psychosom Res. 
Effect of captopril on recuperation from ischemia/reperfusion-induced AKI Nephrology Dialysis Transplant
Restless legs syndrome in dialysis: comparison of hemodialysis & CAPD: Dr. Merlino Neurol Sci.
International practice patterns & non-conventional hemodialysis utilization : Dr. Sood BMC Nephrology 
Decreased PON1 in hemodialyzed & renal transplanted patients. Dr. Paragh Nephrol. Dial. Transplant
Preoperative Proteinuria & Long-Term Progression to Chronic Dialysis & Mortality after CABG: Drs. Chao & Ko : PLoS ONE
Creatinine generation is reduced in CVHD & predicts mortality: Dr. Wilson: Nephrology Dialysis Transplant
Importance of normohydration for the long-term survival in hemodialysis : Dr. Wabel
Nephrology Dialysis Transplant
Local Tissue Renin-Angiotensin System Activation in Cardiorenal Metabolic Syndrome & Type 2 Diabetes: Dr.Hayden Cardiorenal Med
Group I nonreciprocal inhibition in restless legs syndrome secondary to CKD : Dr. Marconi Parkinsonism & Related Disorders 
Low-Dose ESAs and CV Geometry in CKD: Is Darbepoetin-α More Effective than Expected? Dr. Di Lullo
Cardiorenal Med
Pharmacotherapy to improve outcomes in vascular access surgery: Dr. Jackson
Nephrology Dialysis Transplant
Parathyroidectomy for the attainment of NKF-K/DOQI™ and KDIGO recommended values for bone & mineral metabolism in dialysis with uncontrollable secondary hyperparathyroidism. Langenbecks Arch Surg
Bisphosphonate Therapy, Death, and Cardiovascular Events Among Female Patients With CKD: Dr. Perkins
Losartan prevents the development of the pro-inflammatory monocytes CD14+CD16+ in hemodialysis : Dr. Merino Nephrology Dialysis Transplant
Does Dialysis Modality Influence the Oxidative Stress of Uremia? Dr. Capusa  Kidney Blood Press Res
Treatment of Periodontal Diseases Reduces Inflammation in Hemodialysis : Dr. Siribamrungwong
Declining Rates of Deceased Donor Renal Transplantation in the US Over Successive Years of Listing: Dr. Trivedi
When Is the Best Moment to Assess the Ankle Brachial Index: Pre- or Post-Hemodialysis?Dr. RM Elias
Role of Race and Poverty on Steps to Kidney Transplantation in the Southeastern US
Validity & Reliability of the MUST and MST Nutrition Screening Tools in Renal Inpatients : C. Lawson
Target-Orientated Algorithm for Regional Citrate-Calcium Anticoagulation in Extracorporeal Therapies: Dr. Brandl
Evaluation of bone microarchitecture by HR-pQCT in hemodialysis : Dr. Negri
Erectile Dysfunction in Chronic Hemodialysis : Dr. Strippoli
Have Renal Dietitians Successfully Implemented Evidence-Based Guidelines Into Practice? E. Joy
Regional Citrate Versus Heparin Anticoagulation for CRRT: Drs. Tam & Wu
von Willebrand factor predicts mortality in CRRT : Dr. Péquériaux
Clinical Outcome of Twice-Weekly Hemodialysis Patients in Shanghai | Dr. Qian
Persistently low intact PTH levels predict aortic arch calcification progression in hemodialysis patients : Dr. Song
Lack of Awareness among Future Medical Professionals about the Risk of Consuming Hidden Phosphate-Containing Processed Food & Drinks : Dr. Razzaque
51Cr-EDTA plasma & urinary clearance as a measure of residual renal function in dialysis :Dr. Kjaergaard
Obesity and Mortality Risk among Younger Dialysis Patients: Dr. Hoogeveen
Solar-Assisted Hemodialysis: Dr. Agar
Hydrogen sulfide inhibits high glucose-induced matrix protein synthesis by activating AMP-activated protein kinase in renal epithelial cells Drs. Lee & Kasinath
Mineral, bone disorders, survival in hemodialysis with & without PKD : Drs. Molnar & Kalantar-Zadeh
Hydrogen sulfide inhibits high glucose-induced matrix protein synthesis by activating AMP-activated protein kinase in renal epithelial cells Drs. Lee & Kasinath
Mineral, bone disorders, survival in hemodialysis with & without PKD : Drs. Molnar & Kalantar-Zadeh
Downregulation of the renal & hepatic hydrogen sulfide-producing enzymes and capacity in CKD - Dr. Vaziri
A predictive algorithm for management of anemia in hemodialysis based on ESA pharmacodynamics : Dr. Lines
Factors Associated With Intradialytic Systolic Blood Pressure Variability: Dr. Flythe
Safety and predictors of complications of renal biopsy in the outpatient setting : Dr. Jiang
Heparin induced antibodies in chronic hemodialysis patients and cardiac surgery patients: Dr. Shavit
Atrial Fibrillation in Medicare/Medicaid-eligible dialysis patients: Dr. Wetmore
Newly identified anorexigenic adipokine nesfatin-1 in hemodialysis patients: J. Saldanha
Correction of Post kidney Transplant Anemia Reduces Progression of Allograft Nephropathy: Dr. Choukrou
Mild and moderate pre-dialysis CKD is associated with increased coronary artery calcium: Dr. Budoff
Endogenous factors modified by hemodialysis and accuracy of blood glucose-measuring device: Dr. Ogawa
Narrow-band UVV increases serum vitamin D levels in hemodialysis patients Dr. Ala-Houhala
Predicting hospital cost in CKD patients through blood chemistry values: Dr. Bessette
Nutritional vitamin D supplementation in hemodialysis: a potential vascular benefit? D. Mason
Volume excess in chronic hemodialysis effects of treatment frequency & treatment spacing : Dr. Schneditz
Acid reduction with fruits/veges or bicarb attenuates kidney injury in hypertensive nephropathy with reduced GFR
Predicting Number of US Medical Graduates Entering Adult Nephrology Fellowships
Using Search Terms Dr. Desai
Potential influence of sevelamer hydrochloride on responsiveness to ESAs in hemodialysis patients: Dr. Ikee
Anemia Management in Dialysis : ESAs vs Transfusions: Clinical & Economic Consequences :Dr. Naci
Increased risk of death and de novo chronic kidney disease following reversible acute kidney injury: Dr. Perkins
Filtration Markers May Have Prognostic Value Independent of Glomerular Filtration Rate : Dr. Tangri
Stopping Renin-Angiotensin System Inhibitors in Chronic Kidney Disease: Predictors of Response
Insights into nephrologist training, clinical practice, and dialysis choice: Dr. Mehrotra
Early ACE inhibition in Alport syndrome delays renal failure and improves life expectancy: Dr. Gross
Blunted insulinemia using high dialysate glucose concentration during hemodialysis : Dr. Schneditz
Prevalence of Inadequate Platelet Inhibition by Clopidogrel in Patients Receiving Hemodialysis: Dr. Alexopoulos
Live kidney donation: attitudes towards donor approach, motives and factors promoting donation: Dr. Mazaris
High-dose ESAs, inflammatory biomarkers, and soluble erythropoietin receptors : Dr. Inrig
Association of AKI with Adverse Outcomes in Burned Military Casualties : Dr. Stewart
Sodium Intake, ACE Inhibition, and Progression to ESRD Dr. Ruggenenti
DOPPS Practice Monitor: Update on Trends in US Hemodialysis Care Following Launch of Bundled Payment System and Revisions to ESA Labels January 6 2011

Emerging trends in hemodialysis care through August 2011, based on a sample of US dialysis facilities, are included in the latest update to the DOPPS Practice Monitor (DPM, at http://www.dopps.org/DPM), run by the Dialysis Outcomes and Practice Patterns Study (DOPPS) at Arbor Research Collaborative for Health.

Ongoing Changes in the US Dialysis Environment – Recent changes in dialysis payment and regulatory guidance are expected to affect hemodialysis practice. In January 2011, the Centers for Medicare & Medicaid Services (CMS) launched a new Prospective Payment System (PPS) with the intent to control dialysis costs through bundled payments. In June 2011, the FDA approved revised prescribing information for erythropoiesis-stimulating agents (ESAs), used to treat anemia in most dialysis patients. Previously, the label recommended a hemoglobin target range of 10-12 g/dL. The June 2011 update removed the target range, advising instead to start ESA therapy for dialysis patients at hemoglobin less than 10 g/dL, and to reduce or interrupt the dose when the hemoglobin approaches or exceeds 11 g/dL.

Most Recent Trends in Care – Over the August 2010 to August 2011 time period, many hemodialysis practices have remained stable; examples include nutrition measures and hemodialysis treatment time and dose. There have been notable trends in the following practice areas:

  • Anemia: Hemoglobin levels have decreased since the June 2011 ESA label update. While the mean hemoglobin level declined by 0.12 g/dL over 12 months from August 2010 to July 2011, it declined in August 2011 by another 0.10 g/dL to 11.26 g/dL. The percentage of patients with hemoglobin levels greater than 12 g/dL declined sharply (from 28% to 23%) in July/August 2011, while the percentage with hemoglobin levels less than 10 g/dL increased slightly from 8.5% to 10% and the percentage with hemoglobin levels less than 9 g/dL remained under 3%.

Mean prescribed epoetin dose (among patients receiving epoetin) decreased by 15%, from 21,100 units/wk to 17,900 units/wk, from August 2010 to August 2011, with the greatest decline in June-August 2011. Epoetin doses at the higher end of the dose range have decreased most notably. IV iron use increased from August 2010 to August 2011 though has recently stabilized. In keeping with greater IV iron use, serum ferritin levels (indicative of iron stores) continue to rise. Serum ferritin concentration exceeded 500 ng/mL in 65% of patients, 800 ng/mL in 34% of patients, and 1,200 ng/mL in 11% of patients in August 2011.

  • Mineral & Bone Disorder: In our last report, we noted a 29% increase in serum parathyroid hormone (PTH) levels through April 2011, and differences by race were described. Since then, PTH levels have remained stable or declined slightly in both black and non-black patients. In August 2011, 22% of black patients and 12% of non-black patients had very high PTH values (defined here as PTH >600 pg/mL). The percentage of hemodialysis patients for whom PTH is measured has declined slightly since August 2010. There have been no clear changes in serum calcium or serum phosphorus levels.
  • Clinical Outcomes: Preliminary data indicate that the 30-day hospitalization rate has increased somewhat from August 2010 to August 2011. The DPM does not report yet on trends in red blood cell transfusions, as dialysis units are often unaware of transfusions occurring in the inpatient setting. Additional efforts to comprehensively monitor trends in transfusions are warranted. To date mortality rate has not changed appreciably, though further follow-up time is necessary as we continue to track this outcome.

Future monitoring of these trends, confirmation with national data when eventually available, and understanding their effect on clinical outcomes, if any, is required.

DPM data are aggregated across dialysis organizations and facilities. Aggregated trends may not reflect trends in individual dialysis organizations or facilities, and are not intended to provide oversight of performance in individual dialysis organizations or facilities.

Read the rest of the DOPPS Practice Monitor: Update on Trends in US Hemodialysis Care Following Launch of Bundled Payment System and Revisions to ESA Labels Press Release

 
Hemodialysis Patient: Calciphylaxis after skin biopsy - Joerg Latus

Early Stages of Calciphylaxis:
Are Skin Biopsies the Answer?

Joerg Latus, MD
Open Access

Case Rep Dermatol 2011;3:201-205


 

Hemodialysis Research Interview of the Week

Author Interview: Dr. Len Usvyat PhD
Clinical Systems Database Senior Analyst
Renal Research Institute

Seasonal Variations in Mortality, Clinical, and Laboratory Parameters in Hemodialysis Patients: A 5-Year Cohort Study.

Usvyat LA, Carter M, Thijssen S, Kooman JP, van der Sande FM, Zabetakis P,
Balter P, Levin NW, Kotanko P.
 Clin J Am Soc Nephrol. 2011 Nov 17.

What are the main findings of the study?

We found that mortality of hemodialysis patients followed a seasonal pattern over a five year period with the highest mortality in the winter and lowest mortality in the summer months.

We also observed that many clinical and laboratory parameters follow a seasonal pattern in our patient population.

For example, pre-dialysis systolic blood pressures are highest in winter and lowest in summer months; pre-dialysis body temperatures are highest in summer and lowest in winter months.

Neutrophils are highest in winter and lowest in summer suggesting higher inflammatory markers in the winter.

This phenomena was observed in various geographic regions in US.

Were any of the findings unexpected?

It has been previously shown that mortality follows seasonal trends in healthy population however these findings were never extended to dialysis patients.

While it was shown that blood pressures tend to follow a seasonal pattern, to the best of our knowledge, it has not been shown that neutrophils or interdialytic weight gains also follow a seasonal pattern.

Additionally, we applied a cosinor analysis to show whether these patterns are statistically significant.

What should clinicians and patients take away from this study?

These findings are particularly important in designing studies -- taking season into account is key.

What recommendations do you have for future studies as a result of your study?

Further research into understanding the biologic factors that contribute to this seasonality is important.

 


 
 
 
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