View attached explanation and answer. Let me know if you have any questions.hi buddyi completed the taski attached the presentation on powerpoint (including notes in the notes section) and a pdf file with notes i was very happy to work with youdo not hesitate if you have questions regarding this taskand i will be very happy if you invite me privately for next tasks😇DARBEPOETIN ALFA ONCE MONTHLYCORRECTS ANAEMIA IN PATIENTSWITH CHRONIC KIDNEY DISEASE NOTON DIALYSISSimon D Roger, Elena Kolmakova, Maple Fung, Robert Malecki, JoséVinhas, Frank Dellanna, Mark Thomas, Nick Manamley, Sándor FerencziNephrology (Carlton). 2014; 19(5): 266-274Presentation by: Student NameStudy background information Intervention: comparison of darbepoetin alfa oncemonthly dose to every two weeks dose to correct anemiain patients with chronic kidney disease, not on dialysis Study design: randomized, double-blind, non-inferiority,active-controlled study Objective: to clinically investigate if darbepoetin alfaadministered once monthly can be used to maintainhemoglobin concentrations in patients with anemia andchronic kidney diseases but not on dialysis. Trial site: The clinical trial was conducted at 95 centers inEurope, Australia, and MexicoRoger SD, Kolmakova E, Fung M, et al. Darbepoetin alfa once monthly corrects anaemia in patients with chronickidney disease not on dialysis. Nephrology (Carlton). 2014;19(5):266-274. doi:10.1111/nep.12214Primary and secondary study endpointsPrimary endpoints: The primary endpoint was hemoglobin change between baseline and theevaluation period (weeks 29–33); the non-inferiority margin was −0.5 g/dLSecondary endpoints: The proportion of subjects achieving both a hemoglobin concentration ≥10.0g/dl and a ≥1.0 g/dl increase from baseline at any time point during the study The proportion of subjects achieving both a mean hemoglobin concentration≥10.0 g/dl and a ≥1.0 g/dl increase from baseline during the evaluation period Time to and darbepoetin alfa dose at first hemoglobin concentration ≥10.0 g/dland ≥1.0 g/dl increase from baseline Hemoglobin concentration at each scheduled time point (every two weeks) Darbepoetin alfa doses over the duration of the studyRoger SD, Kolmakova E, Fung M, et al. Darbepoetin alfa once monthly corrects anaemia in patients with chronickidney disease not on dialysis. Nephrology (Carlton). 2014;19(5):266-274. doi:10.1111/nep.12214Participants and randomization358 participants were randomizedInclusion criteria: adults diagnosed with chronic kidneydiseases, not on dialysis, estimated glomerular filtrationrate of 15-59 mL/min per 1.73 m2, had two consecutivehemoglobin values below 10 g/dL taken at least 7 daysapart, transferrin saturation is greater or equal to 15%Exclusion criteria: patients with the systemichematological disease, gastrointestinal bleeding withinsix months before enrolment, treatment with anerythropoietin stimulating agent, red blood celltransfusion, major surgery, uncontrolled hypertension, ormajor cardiovascular event within 12 weeks beforeenrolmentRandomization:Participants were randomized 1:1 into the two groupsQ2W initial dose was 0.75 μg/kgQM initial dose was 0.5 μg/kgFigure 1: Study profileRoger SD, Kolmakova E, Fung M, et al. Darbepoetin alfa once monthly corrects anaemia in patients with chronickidney disease not on dialysis. Nephrology (Carlton). 2014;19(5):266-274. doi:10.1111/nep.12214DemographicsWomen percentage washigher than men (59.4%) ofall populationThe majority of participantswere white (92.7%) of allpopulationThe majority of participantswere elderly, and the meanage of the total populationwas 67.3 yearsThe underlying diseaseprofile of participants at thebaseline was similar to thetwo groupsRoger SD, Kolmakova E, Fung M, et al. Darbepoetin alfa once monthly corrects anaemia in patients with chronickidney disease not on dialysis. Nephrology (Carlton). 2014;19(5):266-274. doi:10.1111/nep.12214Results: primary endpoint (hemoglobin changebetween baseline and the evaluation period (weeks 29–33), thenon-inferiority margin was −0.5 g/dL)Roger SD, Kolmakova E, Fung M, et al. Darbepoetin alfa once monthly corrects anaemia in patients with chronickidney disease not on dialysis. Nephrology (Carlton). 2014;19(5):266-274. doi:10.1111/nep.12214Results: secondary endpoints (The proportion of subjects achieving both ahemoglobin concentration ≥10.0 g/dl and a ≥1.0 g/dl increase from baseline at (1)any time point during the study and (2) during the evaluation period)97.9% of participants in the Q2Wgroup and 98.1 participants inthe QM group achievedhemoglobin concentration ≥10.0g/dL and ≥1.0 g/dL increase frombaseline at any time92.3% of participants in the Q2Wgroup and 92.2% of participantsin the QM group achievedhemoglobin concentration ≥10.0g/dL and ≥1.0 g/dL increase frombaseline during the evaluationperiodRoger SD, Kolmakova E, Fung M, et al. Darbepoetin alfa once monthly corrects anaemia in patients with chronickidney disease not on dialysis. Nephrology (Carlton). 2014;19(5):266-274. doi:10.1111/nep.12214Results: secondary endpoints (Time to and darbepoetin alfadose at first hemoglobin concentration ≥10.0 g/dl and ≥1.0 g/dl increase frombaseline and darbepoetin alfa doses over the duration of the study)Darbepoetin alfa weightadjusted weekly adjusteddose at baselineDarbepoetin alfa meanweight-adjusted weeklyequivalent dose over theevaluation periodDarbepoetin alfa mean weight-adjustedweekly equivalent dose whenhemoglobin ≥10.0 g/dL and ≥1.0 g/dLincrease from baseline was firstachievedQ2W group0.37 μg/kg per week0.20 μg/kg per week0.35 μg/kg per weekQM group0.37 μg/kg per week0.27 μg/kg per week0.41 μg/kg per week• The ratio of the weekly weight-adjusted doses between the twogroups (QM/Q2W) during theevaluation period was 1.33, Whichmeans that a higher weeklyequivalent dose in the QM groupwas required to meet theobjectives of the study.Roger SD, Kolmakova E, Fung M, et al. Darbepoetin alfa once monthly corrects anaemia in patients with chronickidney disease not on dialysis. Neph…

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