Epogen (epoetin alfa) / Amgen 
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  • ||||||||||  Epogen (epoetin alfa) / Amgen
    Prevalence of Hyporesponse to Erythropoiesis-Stimulating Agents Among Medicare Patients With CKD-Related Anemia According to Absolute or Weight-Based Definitions (Exhibit Hall, Orange County Convention Center, West Building) -  Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_2519;    
    For each patient, we defined months of HR as those where the hemoglobin level for the prior month was <10 g/dL and the current month’s average ESA weekly dose surpassed weight dependent and weight agnostic thresholds: 300 epoetin alfa (epo) units (U)/kg of body weight, 375U/kg, 450U/kg, and 18,000U...In our study, between 7.0% and 31.2% of patients experienced at least one month of HR; however, only a fraction of these (0.4% to 3.0%) were hyporesponsive for at least 60% of the time, reflective of the transient nature of the condition. Further research is needed to understand the clinical trajectories of episodically hyporesponsive patients.
  • ||||||||||  Mircera (methoxy polyethylene glycol-epoetin beta) / Roche, Vifor
    Artificial Intelligence (AI) Tool Decreases Epoetin Beta (Mircera) Drug Exposure and Maintains Hemoglobin at Desired Levels (Exhibit Hall, Orange County Convention Center, West Building) -  Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_2516;    
    Treatment of patients in a real-world setting confirm previous observations where efficacy is maintained over a 12 month period while decreasing epoetin beta dose 29% initially ending with a mean dose of 84 mcg/month (Months 9-12). Further, the tool achieves the stated goal for ESA therapy using the least amount of ESA to avoid transfusion.
  • ||||||||||  Epogen (epoetin alfa) / Amgen
    Journal:  Epoetin alfa in Pediatric Patients With Ventricular Assist Devices: Is It Safe? (Pubmed Central) -  May 14, 2022   
    One patient was able to discontinue ESA therapy secondary to robust improvement in cell line counts at the time of discharge, while the other 3 patients received heart transplant prior to the discontinuation of ESA therapy. An increase in hematocrit of 1% to 5.5% was seen from epoetin initiation to discontinuation.
  • ||||||||||  Eprex (epoetin alfa) / J&J, Epogen (epoetin alfa) / Amgen, Binocrit (epoetin alfa biosimilar) / Medice, Sandoz
    Trial completion date, Trial primary completion date:  EPO-TRAUMA: ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients (clinicaltrials.gov) -  May 12, 2022   
    P3,  N=2500, Recruiting, 
    Conclusion This phase 3 study will provide valuable insight into the safety and efficacy of parsaclisib as a potential treatment for patients with primary wAIHA. Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Mar 2025 --> Dec 2025
  • ||||||||||  Epogen (epoetin alfa) / Amgen
    Genetics Plays a Limited Role in ESA-Hyporesponsiveness and Haemoglobin Outcomes in End-Stage Renal Disease Patients on Haemodialysis (Mini-Orals Hall) -  May 5, 2022 - Abstract #ERAEDTA2022ERA_EDTA_1621;    
    ESA hypoR for epoetin alfa was defined by an erythropoietin resistance index ≥ 2.0 U/kg/wk/g/L [intravenous (IV)] or ≥ 1.33 U/kg/wk/g/L [subcutaneous (SC)], or dose ≥ 450 U/kg/wk (IV) or ≥ 300 U/kg/wk (SC)...GCTA analyses were inconclusive, suggesting high variability in heritability estimates. Significant differences in baseline variables between the AA and EA populations that were also significantly associated with ESA hypoR, haemoglobin and iron outcomes suggested that population-level baseline differences must be considered when identifying at-risk sub-populations.
  • ||||||||||  Epogen (epoetin alfa) / Amgen, NN1213 / Novo Nordisk
    Trial completion, Trial completion date:  High-dose Erythropoietin for Asphyxia and Encephalopathy (clinicaltrials.gov) -  May 3, 2022   
    P3,  N=501, Completed, 
    SC every 4 weeks for maintenance treatment of anemia. Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Apr 2022
  • ||||||||||  Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
    Machine learning application to find patients with lower-risk myelodysplastic syndrome from real-world data. (Available On Demand; 148) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_3925;    
    This suggests the application of machine learning models using EHR data may improve the efficiency of MDS patient identification and screening efforts for research, quality improvement, and clinical care. >*MDS ICD-10 codes: C94.6 and D46.
  • ||||||||||  Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Duvroq (daprodustat) / GSK, Kyowa Kirin
    Clinical, Journal:  Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. (Pubmed Central) -  Apr 27, 2022   
    P3
    ASCEND-D will evaluate the efficacy and safety of daprodustat compared with epoetin alfa or darbepoetin alfa in the treatment of patients with anemia with CKD G5D.This trial is registered with ClinicalTrials.gov: NCT02879305. EudraCT Number: 2016-000541-31; Sponsor Protocol Number: 200807.
  • ||||||||||  Epogen (epoetin alfa) / Amgen
    New P4 trial:  Pharmacological Countermeasures for High Altitude (clinicaltrials.gov) -  Mar 28, 2022   
    P4,  N=18, Recruiting, 
  • ||||||||||  Epogen (epoetin alfa) / Amgen
    Retrospective data, Journal:  Cohort profile: Alliance for Quality Assessment in Healthcare-Dialysis (AQuAH-D) prospective cohort study of patients on haemodialysis in Japan. (Pubmed Central) -  Mar 23, 2022   
    In January 2020, the facilities' median weekly doses of erythropoietin stimulating agent (ESA) and of intravenous vitamin D ranged from 1846 to 9692 IU (epoetin alfa equivalent) and 0.78 to 2.25 µg (calcitriol equivalent), respectively...During the retrospective period (averaging 1.85 years per participant), the incidence rates of any hospitalisation and of hospitalisation due to cardiovascular disease were 67.2 and 12.0 per 100 person-years, respectively. AQuAH-D data will be updated every 6 months and will be available for studies addressing a wide range of research questions, using the advantages of granular data and quality-of-life measurement of ageing patients on haemodialysis.
  • ||||||||||  Epogen (epoetin alfa) / Amgen, NN1213 / Novo Nordisk
    Trial primary completion date:  High-dose Erythropoietin for Asphyxia and Encephalopathy (clinicaltrials.gov) -  Mar 9, 2022   
    P3,  N=501, Active, not recruiting, 
    AQuAH-D data will be updated every 6 months and will be available for studies addressing a wide range of research questions, using the advantages of granular data and quality-of-life measurement of ageing patients on haemodialysis. Trial primary completion date: Jan 2022 --> Oct 2021
  • ||||||||||  Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    ANEMIA OF CHRONIC KIDNEY DISEASE TREATMENT PATTERNS IN NON-DIALYSIS DEPENDENT TREATMENT NAÏVE PATIENTS IN FRANCE (Poster Area (Virtual)) -  Jan 21, 2022 - Abstract #ISNWCN2022ISN_WCN_823;    
    Further research is needed to understand the reasons for anemia therapy discontinuation, especially as new therapies come to market, in order to optimize anemia of CKD management in France. Funding: GSK study 209622, French National Research Agency (ANR-IA-COH-2012/3721), National Clinical Research Program (PHRC2010)
  • ||||||||||  Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Duvroq (daprodustat) / GSK, Kyowa Kirin
    Clinical, Journal:  Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. (Pubmed Central) -  Dec 30, 2021   
    P3
    Among patients with CKD undergoing dialysis, daprodustat was noninferior to ESAs regarding the change in the hemoglobin level from baseline and cardiovascular outcomes. (Funded by GlaxoSmithKline; ASCEND-D ClinicalTrials.gov number, NCT02879305.).