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Peritoneal dialysis darbepoetin

Bradley A Warady, John Barcia, Nadine Benador, Augustina Jankauskiene, Kurt Olson, Ludmila Podracka, Aleksey Shavkin, Poyyapakkam Srivaths, Cynthia J Wong, Jeffrey Petersen
BACKGROUND: Darbepoetin alfa is a commonly prescribed erythropoiesis-stimulating agent (ESA) for correcting anemia in pediatric chronic kidney disease (CKD) patients. However, little information exists on its use in ESA-naïve patients. This study evaluated the efficacy and safety of darbepoetin alfa in pediatric patients initiating ESA therapy. METHODS: One-hundred sixteen pediatric ESA-naïve subjects (aged 1-18 years) with CKD stages 3-5D and hemoglobin (Hb) <10 g/dl from 43 centers in the US, Europe, and Mexico were randomized by age (three groups) and dialysis status (yes vs...
January 2018: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
Laura Amato, Antonio Addis, Rosella Saulle, Francesco Trotta, Zuzana Mitrova, Marina Davoli
BACKGROUND: Several Erythropoiesis-stimulating agents (ESAs) are available to treat anemia in patients with chronic kidney disease (CKD). Questions about the comparability of such therapeutic options are not purely a regulatory or economical matter. Appropriate use of originator or biosimilar in these patients need to be supported by clinical data. Regarding the prevention of blood transfusion, reduction of fatigue, breathlessness and mortality or cardiovascular events, a summary of the comparative efficacy and safety data of these drugs is lacking...
June 23, 2017: Journal of Nephrology
Franz Schaefer, Bernd Hoppe, Therese Jungraithmayr, Günter Klaus, Lars Pape, Mourad Farouk, Janet Addison, Nick Manamley, Karel Vondrak
BACKGROUND: Limited prospective data are available on the long-term safety of darbepoetin alfa (DA) for treating anemia in children with chronic kidney disease (CKD). METHODS: In this prospective, phase IV, observational registry study, children ≤16 years of age with CKD anemia and receiving DA were observed for ≤2 years. Adverse events (AEs), DA dosing, hemoglobin (Hb) concentrations, and transfusions were recorded. RESULTS: A total of 319 patients were included in the analysis (mean age, 9...
March 2016: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
Naoki Washida, Shuji Inoue, Takahiro Kasai, Keisuke Shinozuka, Koji Hosoya, Kohkichi Morimoto, Shu Wakino, Koichi Hayashi, Hiroshi Itoh
New erythropoiesis-stimulating agents with a longer half-life have been developed for the treatment of anemia in patients with end-stage renal disease. This study evaluated the efficacy of darbepoetin alfa (DA) and long-acting epoetin beta pegol (continuous erythropoietin receptor activator, CERA) in patients on peritoneal dialysis (PD). Twenty-nine patients who had undergone PD for at least 6 months and were iron replacement-naïve and negative for inflammatory parameters were enrolled. Hemoglobin (Hgb) levels and blood pressure were evaluated before and after switching from DA to CERA...
October 2015: Therapeutic Apheresis and Dialysis
Tomoyuki Otsuka, Yukinao Sakai, Shizuka Yui, Masami Sukegawa, Anna Suzuki, Koji Mugishima, Yuichiro Sumi, Yusuke Otsuka, Shuichi Tsuruoka
BACKGROUND: Sustained erythropoiesis-stimulating agents (ESAs) have recently been identified as the standard therapeutic agent for anemia in patients undergoing peritoneal dialysis (PD). However, few reports have compared pain between various types of sustained ESAs or between administration routes. Furthermore, the change ratio of the dose of sustained ESAs reportedly ranges from 0.8 to 1.3. In the present study, to compare darbepoetin alfa and epoetin beta pegol (a continuous erythropoietin receptor activator [CERA]), we examined the dolorific differences between administration routes and the effect on anemia by using a chjange ratio of 0...
2015: Journal of Nippon Medical School, Nippon Ika Daigaku Zasshi
James L Pirkle, Carly J Paoli, Greg Russell, Jeffrey Petersen, John Burkart
PURPOSE: Since the Centers for Medicare & Medicaid Services implemented the End-Stage Renal Disease Prospective Payment System, dialysis providers have increasingly focused on balancing resource utilization and quality outcomes for the treatment of anemia in patients undergoing peritoneal dialysis. Limited data exist regarding anemia management outcomes for these patients in US-based dialysis centers after the implementation of the new payment system. METHODS: This was a retrospective, observational, cohort study of stable PD patients with end-stage renal disease who received darbepoetin alfa for anemia management over a 15-month period (April 1, 2011-June 29, 2012)...
November 1, 2014: Clinical Therapeutics
Deirdre Hahn, June D Cody, Elisabeth M Hodson
BACKGROUND: The benefits of erythropoiesis-stimulating agents (ESA) for dialysis patients have been demonstrated. However, it remains unclear whether the efficacy and safety of new, longer-acting ESA given less frequently is equivalent to recombinant human erythropoietin (rHuEPO) preparations. This is an update of a review first published in 2002 and last updated in 2005. OBJECTIVES: This review aimed to establish the optimal frequency of ESA administration in terms of effectiveness (correction of anaemia, and freedom from adverse events) and efficiency (optimal resource use) of different ESA dose regimens...
May 28, 2014: Cochrane Database of Systematic Reviews
Wolfgang Pronai, Ulrich Neyer, Ursula Barnas, Clemens Wieser, Christine Jaeger, Daniel Dekic, Margit Hemetsberger, Alexander R Rosenkranz
ALTERNATE is an international observational study evaluating biweekly darbepoetin alfa (DA) in adult dialysis patients in clinical practice. Austrian ALTERNATE results are presented here (n = 505). The follow-up study ALTERNATE follow-up (AFU) followed Austrian ALTERNATE patients for an additional 12 months (n = 135). Data were collected 6 months before and 12 months after conversion to biweekly dosing and during 12 months of follow-up. The primary measures were hemoglobin concentration 12 months after conversion and at the end of AFU, respectively...
March 2014: Wiener Medizinische Wochenschrift
Motoshi Hattori, Osamu Uemura, Hiroshi Hataya, Shuichi Ito, Masataka Hisano, Toshiyuki Ohta, Shuichiro Fujinaga, Tomoo Kise, Yoshimitsu Gotoh, Akira Matsunaga, Naoko Ito, Tadao Akizawa
BACKGROUND: We evaluated the safety and efficacy of darbepoetin alfa (DA), an attractive alternative to recombinant human erythropoietin (rHuEPO) in managing renal anemia, in Japanese children with chronic kidney disease (CKD) on peritoneal dialysis (PD) and hemodialysis (HD), and not on dialysis (ND). METHODS: A total of 31 pediatric CKD patients (13 PD, 2 HD, and 16 ND) were enrolled. DA was administered bi-weekly intravenously (IV) or subcutaneously (SC) for PD or ND patients, and weekly IV for HD patients for 24 weeks...
August 2014: Clinical and Experimental Nephrology
Bo Ying Choy, Man Fai Lam, Terence Yip, Hon Lok Tang, Ping Nam Wong, Chik Cheung Vincent Chow, Desmond Yh Yap, Tak Mao Chan
AIM: To investigate methoxy polyethylene glycol-epoetin beta dosing regimen in treatment naïve subjects and dose conversion in darbepoetin alpha treated subjects, in Chinese dialysis patients. METHODS: Adult Chinese patients on peritoneal dialysis (PD) or haemodialysis (HD), with no prior treatment with erythropoiesis-stimulating agents and haemoglobin below 8 g/dL (Group I) or receiving darbepoetin alpha and had stable haemoglobin at 10-12 g/dL (Group II) were included in this prospective open-label study...
August 2013: Nephrology
Vicente Escudero-Vilaplana, Concepción Martínez-Nieto, Juan Manuel López-Gómez, Almudena Vega-Martínez, José María Bellón-Cano, María Sanjurjo-Sáez
BACKGROUND: Some publications have shown that equivalent doses of erythropoiesis-stimulating agents (ESA) defined on label differ from those effective in clinical practice. Therefore, real costs could vary from theoretical costs in the treatment of anaemia in chronic kidney disease (CKD). OBJECTIVES: To perform a cost-minimization analysis to establish the economic impact of the principal ESAs used in treating anaemia secondary to CKD in daily practice. SECONDARY OBJECTIVES: to determine patient-month cost based on the erythropoietin resistance index (ERI); to analyze the difference in cost between pre-dialysis and peritoneal dialysis (PD) patients; and to analyze the association between iron deposits and ESA cost...
June 2013: International Journal of Clinical Pharmacy
Ceren Can, Sevinç Emre, Ilmay Bilge, Alev Yilmaz, Aydan Şirin
BACKGROUND: The aim was to compare the clinical efficacy of recombinant human erythropoietin (rHuEPO) and darbepoetin alpha (DA) in the treatment of anemia in children with chronic kidney disease (CKD). METHOD: Thirty-four (13 female, 21 male) CKD patients were enrolled in the study. Mean age was 11.42 ± 4.05 years. Nine patients were on hemodialysis, 18 were on peritoneal dialysis and seven patients were in CKD stage 4. RESULTS: Seventeen patients received rHuEPO and the remaining 17 patients received DA...
June 2013: Pediatrics International: Official Journal of the Japan Pediatric Society
Steven M Brunelli, Keri L Monda, John M Burkart, Matthew Gitlin, Peter J Neumann, Grace S Park, Margarita Symonian-Silver, Susan Yue, Brian D Bradbury, Robert J Rubin
BACKGROUND: Launched in January 2011, the prospective payment system (PPS) for the US Medicare End-Stage Renal Disease Program bundled payment for services previously reimbursed independently. Small dialysis organizations may be particularly susceptible to the financial implications of the PPS. The ongoing Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations (STEPPS) was designed to describe trends in care and outcomes over the period of PPS implementation...
June 2013: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
Motoshi Hattori, Akira Matsunaga, Yuko Akioka, Shuichiro Fujinaga, Takuhito Nagai, Osamu Uemura, Hyogo Nakakura, Akira Ashida, Koichi Kamei, Shuichi Ito, Takuji Yamada, Yoshimitsu Goto, Toshiyuki Ohta, Masataka Hisano, Yasuhiro Komatsu, Noritomo Itami
BACKGROUND: Darbepoetin alfa (DA) is an attractive alternative to recombinant human erythropoietin (rHuEPO) in managing renal anemia. Since DA has not been approved by the appropriate Japanese drug regulatory agencies for the indication of renal anemia in children in Japan, we have conducted a multicenter prospective study to determine the efficacy and safety of DA in Japanese children undergoing peritoneal dialysis (PD). METHODS: Pediatric patients subcutaneously receiving rHuEPO were switched to DA treatment for a period of 28 weeks...
August 2013: Clinical and Experimental Nephrology
Katherine A Barraclough, Fiona Brown, Carmel M Hawley, Diana Leary, Euan Noble, Scott B Campbell, Nicole M Isbel, David W Mudge, Carolyn L van Eps, David W Johnson
BACKGROUND: Preliminary clinical evidence suggests that heme iron polypeptide (HIP) might represent a promising, novel oral iron supplementation strategy in chronic kidney disease. The aim of this multi-centre randomized controlled trial was to determine the ability of HIP administration to augment iron stores in darbepoetin (DPO)-treated patients compared with conventional oral iron supplementation. METHODS: Adult peritoneal dialysis (PD) patients treated with DPO were randomized 1:1 to receive two capsules daily of either HIP or ferrous sulphate per os for 6 months...
November 2012: Nephrology, Dialysis, Transplantation
Hiromichi Suzuki, Tsutomu Inoue, Yusuke Watanabe, Tomohiro Kikuta, Takahiko Sato, Masahiro Tsuda, Kousuke Uchida
The newly developed erythropoiesis agent darbepoetin alpha (DA) allows for once-monthly dosing in the treatment of anemia in patients on dialysis. This dosing schedule has prompted some studies to examine the efficacy of DA in patients on continuous ambulatory peritoneal dialysis (CAPD). In the present study, we assessed whether intravenous (IV) administration of DA once monthly is effective for maintaining hemoglobin levels near 10.5 g/dL in patients on CAPD. This single-center prospective cohort study included 52 clinically stable patients (25 men, 27 women; mean age: 59 +/- 10 years)...
2011: Advances in Peritoneal Dialysis
Minoru Kubota, Makoto Hiramatsu, Masato Yamakawa, Shunichi Fukuhara, Satoshi Morita, Manabu Iwasaki, Tadao Akizawa
BACKGROUND: Darbepoetin alfa (KRN321) is a recombinant protein that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Due to its longer half-life and greater biological activity than recombinant human erythropoietin (rHuEPO), KRN321 maintains an effective hemoglobin (Hb) level at extended dose intervals compared with rHuEPO. The efficacy and safety of KRN321 administered subcutaneously to patients on peritoneal dialysis (PD) were tested. METHODS: In a multicenter, open-label, single-arm study, KRN321 was administered subcutaneously to patients on PD for 26-28 weeks...
December 2011: Clinical and Experimental Nephrology
M Battistella, R M A Richardson, J M Bargman, C T Chan
BACKGROUND: Uncontrolled hy-per-parathyroidism causes bone marrow fibrosis, leading to erythropoietin (EPO) resistance. Medical treatment with cinacalcet is effective in reducing plasma parathyroid hormone (PTH) levels, but its effect on darbepoetin dosing is unknown. METHODS AND AIMS: We conducted a retrospective cohort study of 40 end-stage renal disease (ESRD) patients (age: 55 ± 14; mean ± SD; 21:male) who had at least 12 months of cinacalcet therapy. The distribution of renal replacement therapies were: 14 peritoneal dialysis, 18 conventional hemodialysis and 8 nocturnal hemodialysis...
August 2011: Clinical Nephrology
Mariano Feriani, Johan M J De Meester, Lawrence P McMahon, Jacques B Rottembourg, Ian Bridges, Mourad Farouk, Wolfgang Pronai
BACKGROUND: Anemia is common among peritoneal dialysis (PD) patients, and most patients require erythropoiesis-stimulating agents (ESA) to maintain their hemoglobin concentrations within current guideline recommendations. Darbepoetin alfa is an ESA with a 3-fold longer half-life and greater in vivo biological activity than recombinant human erythropoietin, allowing less frequent dosing that may simplify anemia management in these patients, providing benefits to patients, care givers and health care providers...
2011: BMC Nephrology
Maaz Ahmed Abbasi, Glenn M Chertow, Yoshio N Hall
INTRODUCTION: End-stage renal disease (ESRD) affects more than 1500 people per million population in countries with a high prevalence, such as Japan, Taiwan, and the US. Approximately two-thirds of people with ESRD receive haemodialysis, one quarter have kidney transplants, and one tenth receive peritoneal dialysis. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of different doses for peritoneal dialysis? What are the effects of different doses and membrane fluxes for haemodialysis? What are the effects of interventions aimed at preventing secondary complications? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review)...
2010: Clinical Evidence
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