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Cited by 31Erythropoietin and Anemia TreatmentBiosimilars and Bioanalytical MethodsIron Metabolism and Disorders

Pharmacokinetic and pharmacodynamic profiles of extended dosing of epoetin alfa in anemic patients who have chronic kidney disease and are not on dialysis

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McGowan, Tracy, Vaccaro, Nicole M., Beaver, Jessica S., Massarella, Joseph, Wolfson, Marsha·2008·Clinical Journal of the American Society of Nephrology
DOI 10.2215/cjn.05671207PMC PMC2440285
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Abstract

BACKGROUND AND OBJECTIVES: Emerging evidence suggests that epoetin alfa can be administered at extended intervals of up to 4 wk. This open-label, randomized study was performed to characterize the pharmacokinetic and pharmacodynamic profiles of four dosing regimens of epoetin alfa administered subcutaneously in anemic patients who had chronic kidney disease and were not on dialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Thirty-eight patients, enrolled from nine centers in the United States, were > or =18 yr of age and had hemoglobin <11.0 g/dl and GFR 12 to 60 ml/min per 1.73 m(2). Patients received one of four epoetin alfa dosing regimens: 50 IU/kg three times per week, 10,000 IU once weekly, or 20,000 IU every 2 wk for 36 d or 40,000 IU every 4 wk for 64 d. Each regimen provided a similar dosage of epoetin alfa over 4 wk. Dosage adjustments were not permitted. RESULTS: Drug exposure to epoetin alfa over 4 wk, based on area under the curve, was somewhat higher with the extended interval regimens compared with the three-times-weekly regimen. Mean change in hemoglobin during the study period was similar for all regimens. No patients were transfused. Three patients experienced five serious adverse events, none of which was considered treatment related. CONCLUSIONS: Extended dosing interval regimens of epoetin alfa yielded modest pharmacokinetic differences but a similar pharmacodynamic response, suggesting that less frequent, higher dosages of epoetin alfa may be as effective as the current three-times-weekly regimen in anemic patients who have chronic kidney disease and are not on dialysis.

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  • In healthy volunteers and anemic patients with chronic kidney disease, a dose of recombinant erythropoietin of about 600 IU/kg led to an increase of the percentage of reticulocytes of about 2.

    “In healthy volunteers as well as anemic patients with chronic kidney disease, a dose of recombinant erythropoietin of about 600 IU/kg (which appears to be among the highest usually applied in clinical settings) led to maximum serum EPO levels of about 1,000 mIU/ml and an increase of the percentage of reticulocytes of about 2.39,40”

    From Sequence-engineered mRNA without chemical nucleoside modifications enables an effective protein therapy in large animals (2015) · cites this paper as [40]

  • A dose of recombinant erythropoietin of about 600 IU/kg appears to be among the highest usually applied in clinical settings.

    “(which appears to be among the highest usually applied in clinical settings)”

    From Sequence-engineered mRNA without chemical nucleoside modifications enables an effective protein therapy in large animals (2015) · cites this paper as [40]

  • In healthy volunteers and anemic patients with chronic kidney disease, a dose of recombinant erythropoietin of about 600 IU/kg led to maximum serum EPO levels of about 1,000 mIU/ml.

    “In healthy volunteers as well as anemic patients with chronic kidney disease, a dose of recombinant erythropoietin of about 600 IU/kg (which appears to be among the highest usually applied in clinical settings) led to maximum serum EPO levels of about 1,000 mIU/ml and an increase of the percentage of reticulocytes of about 2.39,40”

    From Sequence-engineered mRNA without chemical nucleoside modifications enables an effective protein therapy in large animals (2015) · cites this paper as [40]

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Authors
McGowan, T., Vaccaro, N. M., Beaver, J. S., Massarella, J., & Wolfson, M.
Affiliations
Janssen Research & Development (United States) (US)
Corresponding author
Wolfson, Marsha
Venue
Clinical Journal of the American Society of Nephrology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2008-07
Volume
3
Issue
4
Pages
1006-1014
ISSN
1555-9041 (ISSN-L)
DOI
10.2215/cjn.05671207
PMC
PMC2440285
OpenAlex
W2097391350
Cited by
31
References
15
Citations by year
2026: 1 · 2023: 1 · 2021: 2 · 2019: 1 · 2018: 4 · 2017: 2 · 2015: 3 · 2014: 3 · 2013: 1
FWCI
2.58
Type
journal article
Language
en
Open access
Locations
  • Clinical Journal of the American Society of Nephrology (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Hematology › Erythropoietin and Anemia Treatment
  • Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
  • Health Sciences › Medicine › Hematology › Iron Metabolism and Disorders
Keywords
epoetin alfa, extended dosing interval, chronic kidney disease, anemia of chronic kidney disease, pharmacokinetics, pharmacodynamics, hemoglobin response, subcutaneous administration, dosing regimen, drug exposure
MeSH terms
Epoetin Alfa, Aged, Aged, 80 and over, Anemia, Chronic Disease, Dialysis, Drug Administration Schedule, Erythrocyte Count, Erythropoietin, Female, Hematinics, Hemoglobins, Humans, Injections, Subcutaneous, Kidney Diseases, Male, Middle Aged, Prospective Studies, Recombinant Proteins, United States, Treatment Outcome, Reticulocyte Count

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