2023Vifor (International) Inc. All rights reserved. The site is secure. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. Nephrol Dial Transplant. 2. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2).
Methoxy polyethylene glycol-epoetin beta - Wikipedia Anemia: an early complication of chronic renal insufficiency. Months 7 to 1 constituted the pre-switch period, with switch defined as the date of first administration of PEG-Epo, and Months +1 to +7 constituted the post-switch period.
Mircera (methoxy polyethylene glycol / epoetin beta) dosing - Medscape Eligible patients had received hemodialysis for 12 months and DA for 7 months. An additional analysis was performed to explore the effect of transfusions on the DCR, by exclusion of patients with a transfusion within 90days prior to or during either EP from the analysis. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. 2). pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period.
Mircera Injection: Uses, Dosing & Side Effects - Drugs.com Evaluate the iron status in all patients before and during treatment. -. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. The information provided in this site is intended only for healthcare professionals in the United States. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . MIRCERA is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: MIRCERA is not indicated and is not recommended for use: MIRCERA has not been shown to improve quality of life, fatigue, or patient well-being. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. Available for Android and iOS devices. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m
ZJ7CY\7\lO7OGPno? [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). The conversion rate was 354:1 in patients requiring high (>200 IU/kg/week) doses of epoetin and 291:1 in patients requiring low doses. Carrera F, Lok CE, de Francisco A, et al. The aims of the Aranesp Efficiency Relative to Mircera (AFFIRM) study were primarily to estimate the maintenance dose conversion ratio (DCR) of PEG-Epo to DA in a population of European hemodialysis patients switched from DA to PEG-Epo and with comparable mean hemoglobin (Hb) in the pre- and post-switch periods, and secondarily to investigate parameters of clinical management of anemia in this group of patients, in real-world clinical practice. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp and EPOGEN are not approved). _____ (if . Statistical methods for assessing agreement between two methods of clinical measurement. Discontinue MIRCERA, When administered subcutaneously, MIRCERA. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). MIRCERA, methoxy polyethylene glycol-epoetin beta, is an ESA which differs from erythropoietin through formation of a chemical bond between an amino group present in erythropoietin beta and methoxy polyethylene glycol (PEG) butanoic acid. In these hemodialysis patients switched from DA to PEG-Epo the DCR was 1.17 and 1.21 after accounting for the effect of transfusions. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period.
Comparison Among Erythropoietin Stimulating Agents MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. There are limitations in generalizing the findings of this study to the broader hemodialysis population. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. - , . Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures. The recommended RETACRIT regimens are: 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. This paper presents the findings of a retrospective, multi-center, observational study of hemodialysis patients switched from DA to PEG-Epo for the treatment of anemia. Data were collected from 7months before until 7months after switching treatment. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. 10PAGE BROCHURE
Mourad Farouk is an employee of Amgen with Amgen stock ownership. Correspondence to OZZ When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Internal You are now leaving AnemiaHub.com.
Mircera Dosage Guide - Drugs.com 1985;28:15. Dr. Gerald Diaz @GeraldMD.
Product Information and Dosing | Mircera There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Epub 2014 Nov 1. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . Appropriately control hypertension prior to initiation of and during treatment with MIRCERA, Seizures have occurred in patients participating in MIRCERA, For lack or loss of hemoglobin response to MIRCERA, If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo. Logistic regression was used to estimate an odds ratio comparing the number of patients receiving an RBC transfusion in the post-switch period relative to their dose ratio at switch (<1 vs. 1). Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. This analysis indicated that the concordance decreased with increasing dose. Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Examine each prefilled syringe for the expiration date. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. 1. Results: [citation needed] In an additional analysis performed to assess the sensitivity of this result to the effects of transfusion by excluding those patients who received an RBC transfusion within 90days prior to or during either evaluation period, the DCR was 1.21 (95% CI 1.09, 1.35). AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. in the treatment of anemia due to cancer chemotherapy. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. (0.6MB), Anemia Assessment and Management Brochure, Pathophysiology of Anemia in Patients with CKD, * Case studies and patient profiles are hypothetical, WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these
Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) CAS If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. ribosome A ribonuclear protein complex that binds to mRNA nucleotide A basic . AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo. Logistic regression analysis showed a higher likelihood of a transfusion during the post-switch period among patients with a dose ratio at switching of <1. Methoxy polyethylene glycol-epoetin beta injection is used to treat anemia in adults with chronic kidney disease (CKD) who may or may not be on dialysis or in children with CKD who are on dialysis. If Hb increases by < 1 g/dL and remains < 10 g/dL after 6 weeks of therapy: If dosing QW, then increase dose to 4.5 mcg/kg/week. 1986;327:30710. doi: 10.1001/archinte.162.12.1401. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. The study comprised a 14-month observation period.
Pharmacotherapy Update - Automatic Therapeutic Interchange Program ?Ij{JVv:oC*#]}V#$M_T.zC>~] L%lq[Tn`QbWB./@ClVgrk)U-j#(0(D Google Scholar. Mircera will be administered IV to HD patients, and SC to PD patients. Administer Mircera as an intravenous injection at the dose (in micrograms) based on the total weekly ESA dose at the time of conversion (see Table 2). History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). The initial conversion factor was 200:1. Methoxy polyethylene demonstrated that the dose efficiency after SC and IV ad- glycol-epoetin b (PEG-epoetin b; Mircera; F. Hoffmann- ministration was . Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Injection: 30 mcg, 50 mcg, 75 mcg, 100 mcg, 120 mcg, 150 mcg, 200 mcg, or 250 mcg in 0.3 mL solution in single- 4! volume30,pages 10071017 (2013)Cite this article. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. FOIA Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial.
Conversion Dosing Guide: from Epoetin Alfa to Aranesp in Patients with Methoxy polyethylene glycol-epoetin beta injection causes the . By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. The regression analysis that examined the relationship between mean weekly ESA doses in the two evaluation periods indicated that the DCR is not linear; a significant (P=0.008) quadratic term was observed in the regression analysis, indicating that the predicted DCR decreased at higher pre-switch doses of DA (Fig.
Dose Conversion Ratio in Hemodialysis Patients Switched from 1:1 reference line, BlandAltman analysis of agreement between, BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose ( n, Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period., Red blood cell transfusions pre- and post-switch, Summary of the last hemoglobin concentrations recorded within 14 days prior to red, MeSH Anemia of end-stage renal disease (ESRD). Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. The MHRA is aware of very rare cases of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, in patients treated with erythropoietins; some cases were fatal. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. Mircera works like the human protein called erythropoietin to help your body make more RBCs. | DOWNLOAD SIZE:
Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN.
Mircera solution for injection in pre-filled syringe - Summary of 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. Google Scholar. Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. The geometric mean weekly ESA doses were 24.1 g DA in the pre-switch EP and 28.6 g PEG-Epo in the post-switch EP. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| In pediatric patients, Mircera is administered by intravenous injection only (2.2). Conclusion: A dose approximating 0. Discard any unused portion. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Therapeutic effects . Evaluation of Iron Stores and Nutritional Factors. Arch Intern Med. In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. m+KqXAXOkS@,1C0VgzXzeWU},4 doi: 10.1053/ajkd.2001.27699. <>
Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. However, healthcare-resource utilization and cost data were not collected in this study, preventing comparison of these variables between the pre-switch and post-switch periods. doi: 10.1053/j.ajkd.2011.11.013. Am J Kidney Dis. Canaud B, Mingardi G, Braun J, et al. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Geometric mean weekly PEG-Epo dose at Month 1 post-switch was 26.7g (95% CI 24.4, 29.3), rising to 29g (95% CI 26.2, 32.2) by Month 7 post-switch. DCR was calculated for patients with Hb and ESA data available in both evaluation periods (EP; Months 1 and 2 were defined as the pre-switch EP, and Months 6 and 7 as the post-switch EP). 3 0 obj
By definition, the DCR could not be calculated for patients ineligible for the DCR analysis as these did not have the necessary parameters recorded in both EPs. Conversion from Another ESA: dosed once every 4 weeks based on total 3 DOSAGE FORMS AND STRENGTHS. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. Of 302 patients enrolled, 206 had data available for DCR analysis. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. and darbepOetin alfa in patieNts Undergoing dialySis [PATRONUS] [9]); however, there is a lack of published literature on switching in patients receiving routine clinical care (i.e., outside interventional clinical trials). This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
MIRCERA- methoxy polyethylene glycol-epoetin beta Insertion mechanism for drug delivery device - AMGEN INC. ^D[5j@%e WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE CHRONIC KIDNEY DISEASE: Please see full Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. Please click the OK button below to continue. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
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Bethesda, MD 20894, Web Policies 2002;162:14011408. New anemia therapies: translating novel strategies from bench to bedside. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Nephrol Dial Transplant. In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 to 14 g/dL) to lower targets (9 to 11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups. A single hemoglobin excursion may not require a dosing change.
MIRCERA has an approximate molecular weight of 60 kDa. PubMed There was neither any requirement for a center to have been using DA as their sole long-acting ESA pre-switch, nor for every DA-treated patient to have been switched to PEG-Epo. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 2002;162:14018. This compares with a 35% decline in Epogen sales during the same period to $1.13bn, as competition from Mircera and biosimilars, like by Sandoz' Binocrit, reach the markets. DA, launched in 2001 [5, 7], contains 5 N-linked oligosaccharide chains, rather than the 3 contained in short-acting epoetins, which confer an approximately threefold longer serum half-life and mean residence time, allowing extended inter-dosing intervals [6]. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. This medicine is not for treating anemia caused by cancer chemotherapy. 2008;23:365461. Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. In order to compare stable clinical scenarios for the purposes of DCR calculation, data evaluation periods (EPs) were utilized: Months 2 and 1 were defined as the pre-switch EP and Months +6 and +7 were defined as the post-switch EP. x]r9r}W#k Janet Addison is an employee of Amgen with Amgen stock options. pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. Evaluate the iron status in all patients before and during treatment. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic
The dose of MIRCERA , given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of conversion. The https:// ensures that you are connecting to the Kazmi WH, Kausz AT, Khan S, et al. These adverse reactions included myocardial infarction and stroke. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J.
Prise en charge anmie rnale - Nephro.blog .
Mircera solution for injection in pre-filled syringe Hrl WH. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. As the study was entirely retrospective, ESA switching and dose conversion were performed without reference to a study protocol and there was no protocol-driven intervention in the clinical management of patients. 3. Clipboard, Search History, and several other advanced features are temporarily unavailable. The mean (95% CI) monthly Hb immediately prior to switch, in Month 1 post-switch, and in Month 7 post-switch was 11.5g/dL (11.3, 11.7), 11.7g/dL (11.5, 11.9), and 11.4g/dL (11.3, 11.6), respectively. If severe anemia and low reticulocyte count develop during treatment with Aranesp or EPOGEN, withhold Aranesp or EPOGEN and evaluate patients for neutralizing antibodies to erythropoietin. The baseline (i.e., at time of switch) demographic and clinical characteristics of enrolled patients and those included in and excluded from the DCR analysis are displayed in Table1. Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. 2012;59:44451. 2001;38:803812. Disposition of patients. All calculations should be confirmed before use. Choi, P., Farouk, M., Manamley, N. et al. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>>
An observational cohort study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study. Packaging Type: Injection. Composition: Methoxy Polyethylene Glycol-Epoetin Beta.
Procrit dosing calculator | Math Applications Do you wish to proceed? Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. . The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Mircera may be used alone or with other medications. Slider with three articles shown per slide. For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. Medically reviewed by Drugs.com. PubMed
Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in Drug class: Recombinant human erythropoietins. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. Eligible patients had received hemodialysis for 12months and DA for 7months. doi: 10.1093/ndt/17.suppl_5.66. Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease.
Mircera | European Medicines Agency PDF Methoxy polyethylene glycol-epoetin beta (Mircera ) Protocol For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. 2022;53(5):333-342. doi: 10.1159/000523947. Adv Ther 30, 10071017 (2013). For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. 3. Regardless of possible differences in their clinical characteristics it should be borne in mind that patients were not selected for inclusion in the DCR analysis on the basis of their fulfilling any clinical, Hb or ESA dose requirements: all patients who had Hb measurements in both EPs, a DA dose in the pre-switch EP and a PEG-Epo dose in the post-switch EP were eligible for inclusion.