Conversion from Epoetin Alfa to Darbepoetin Alfa in Hemodialysis Patients: Effectiveness and Variability in Anemia Treatment
(Source: Journal of Renal Nutrition)
Source: Journal of Renal Nutrition - February 27, 2020 Category: Urology & Nephrology Source Type: research

Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study.
CONCLUSIONS: Mixed HDF decreased darbepoetin-alfa requirement in dialysis patients. This might help preventing the untoward side effects of high ESA doses, besides having a remarkable economic impact. Additional evidence is needed to confirm this potential benefit of Mixed-HDF. PMID: 32036610 [PubMed - as supplied by publisher] (Source: Journal of Nephrology)
Source: Journal of Nephrology - February 7, 2020 Category: Urology & Nephrology Authors: Pedrini LA, Comelli M, Ruggiero P, Feliciani A, Manfrini V, Cozzi G, Castellano A, Pezzotta M, Gatti G, Arazzi M, Auriemma L, di Benedetto A, Stuard S Tags: J Nephrol Source Type: research

Glycan analysis of erythropoiesis-stimulating agents
In this study, a combination of chromatography and mass spectrometry analysis has been used to characterise and compare the glycosylation profiles of five ESA products; Eprex® (epoetin alfa), NeoRecormon® (epoetin beta), Binocrit® (epoetin alfa biosimilar), Silapo (epoetin alfa biosimilar) and Aranesp® (darbepoetin alfa). The methods utilised include mixed-mode anion-exchange/hydrophilic interaction chromatography (AEX/HILIC-MS) for N-glycan identification and quantitation, and HILIC-MS for O-glycan characterisation. The products exhibit notable differences in N- and O-glycosylation, including attributes such as sialic...
Source: Journal of Pharmaceutical and Biomedical Analysis - December 6, 2019 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study
ConclusionThe changes in the level of Hb, dose of erythropoietin, and achievement rate of the target Hb during the study period were comparable between the groups. CKD-11101 has an equivalent efficacy and safety compared with darbepoetin-alfa in patients undergoing hemodialysis. (Source: BioDrugs)
Source: BioDrugs - November 19, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial
Following publication of the original article [1], the authors reported errors in the presentation of Tables 2, 4 and 5. (Source: BMC Nephrology)
Source: BMC Nephrology - November 19, 2019 Category: Urology & Nephrology Authors: Shubhadeep D. Sinha, Vamsi Krishna Bandi, Bala Reddy Bheemareddy, Pankaj Thakur, Sreenivasa Chary, Kalpana Mehta, Vikranth Reddy Pinnamareddy, Rajendra Pandey, Subhramanyam Sreepada and Santosh Durugkar Tags: Correction Source Type: research

Successful perinatal management of a dichorionic diamniotic twin pregnancy in an anaemic kidney transplant patient treated with Darbepoetin alfa: a case report.
Authors: Tamaki S, Shinoda K, Matsumoto T, Morita S, Asanuma H, Yoshida T, Oya M PMID: 31478423 [PubMed - as supplied by publisher] (Source: Journal of Obstetrics and Gynaecology)
Source: Journal of Obstetrics and Gynaecology - September 4, 2019 Category: OBGYN Tags: J Obstet Gynaecol Source Type: research

Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial.
CONCLUSIONS: In patients with anemia of CKD, once-monthly methoxy polyethylene glycol-epoetin beta was noninferior to conventional, shorter-acting erythropoiesis-stimulating agents with respect to rates of major adverse cardiovascular events or all-cause mortality. PMID: 31420350 [PubMed - as supplied by publisher] (Source: Clinical Journal of the American Society of Nephrology : CJASN)
Source: Clinical Journal of the American Society of Nephrology : CJASN - August 15, 2019 Category: Urology & Nephrology Authors: Locatelli F, Hannedouche T, Fishbane S, Morgan Z, Oguey D, White WB Tags: Clin J Am Soc Nephrol Source Type: research

Darbepoetin Alfa Versus Erythropoietin Alfa for Treatment of Renal Anemia in Patients with Chronic Kidney Disease at the Pre-Dialysis Stage: A Randomized Non-inferiority Trial.
Authors: Mehta KS, Sinha SD, Vamsi B, Reddy B, Naidu NR, Thakur PA, Sreenivasa C, Reddy VPR, Pandey R, Durugkar S PMID: 30935177 [PubMed - in process] (Source: Journal of the Association of Physicians of India)
Source: Journal of the Association of Physicians of India - April 4, 2019 Category: General Medicine Tags: J Assoc Physicians India Source Type: research

Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial
The objective of this study was to compare the eff... (Source: BMC Nephrology)
Source: BMC Nephrology - March 13, 2019 Category: Urology & Nephrology Authors: Shubhadeep D. Sinha, Vamsi Krishna Bandi, Bala Reddy Bheemareddy, Pankaj Thakur, Sreenivasa Chary, Kalpana Mehta, Vikranth Reddy Pinnamareddy, Rajendra Pandey, Subhramanyam Sreepada and Santosh Durugkar Tags: Research article Source Type: research

T cell and monocyte/macrophage activation markers associate with adverse outcome, but give limited prognostic value in anemic patients with heart failure: results from RED-HF
ConclusionsLeukocyte activation markers sCD163, MIF, sIL-2R, and ALCAM were associated with adverse outcome in patients with HFrEF, but add little as prognostic markers on top of established biochemical risk markers.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT00358215. (Source: Clinical Research in Cardiology)
Source: Clinical Research in Cardiology - February 1, 2019 Category: Cardiology Source Type: research

Correction to: Safety and effectiveness of long-term use of darbepoetin alfa in non-dialysis patients with chronic kidney disease: a post-marketing surveillance study in Japan
In the original publication of the article, two sentences in the “Results” section were published incorrectly. The corrected texts are provided below: (Source: Clinical and Experimental Nephrology)
Source: Clinical and Experimental Nephrology - January 23, 2019 Category: Urology & Nephrology Source Type: research

Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis.
CONCLUSION: CKD-11101 has an equivalent therapeutic effect as NESP in chronic kidney disease patients with renal anaemia. CKD-11101 can be safely used for long-term treatment and in patients converted from NESP. PMID: 30569763 [PubMed - as supplied by publisher] (Source: Current Medical Research and Opinion)
Source: Current Medical Research and Opinion - December 22, 2018 Category: Research Tags: Curr Med Res Opin Source Type: research

Treatment of Anemia With Darbepoetin Prior to Dialysis Initiation and Clinical Outcomes: Analyses From the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)
ConclusionsDespite initiating dialysis therapy with a higher hemoglobin level, prior treatment with darbepoetin was not associated with a reduction in mortality, myocardial infarction, or heart failure in the first 180 days, but a higher frequency of stroke was observed. In the absence of more definitive data, this may inform decisions regarding the use of erythropoiesis-stimulating agents to treat mild to moderate anemia in patients with type 2 diabetes and chronic kidney disease nearing dialysis therapy initiation. (Source: American Journal of Kidney Diseases)
Source: American Journal of Kidney Diseases - December 19, 2018 Category: Urology & Nephrology Source Type: research

Comparison of the Pharmacokinetic –Pharmacodynamic Relationships of Two Darbepoetin Alfa Formulations in Healthy Male Volunteers
ConclusionThe test and reference darbepoetin alfa formulations had similar PK, PD, and safety profiles. Thus, it is expected that the two formulations are able to be used interchangeably in clinical settings.ClinicalTrials.gov Identifier: NCT03542916. (Source: BioDrugs)
Source: BioDrugs - December 1, 2018 Category: Drugs & Pharmacology Source Type: research

Long-term maintenance of hemoglobin levels in hemodialysis patients treated with bi-weekly epoetin beta pegol switched from darbepoetin alfa: a single-center, 12-month observational study in Japan
AbstractRecent evidence on maintenance administration of epoetin beta pegol, a continuous erythropoiesis receptor activator (CERA), in dialysis patients shows the clinical benefit of bi-weekly administration (Q2W) in improving hematopoiesis and iron use efficiency. We undertook a single-center observational study of 33 Japanese maintenance dialysis patients, whose anemia had been kept stable through weekly administration (Q1W) of darbepoetin (DA), to evaluate the effectiveness of CERA Q2W switched from DA in maintaining hemoglobin (Hb) levels over a 12-month period. The target Hb level was 10.0 –12.0 g/dL. Throughout th...
Source: Journal of Artificial Organs - November 14, 2018 Category: Transplant Surgery Source Type: research