BACKGROUND AND OBJECTIVES: In clinical practice, physicians often use once-weekly (QW) and biweekly (Q2W) dosing of epoetin alfa to treat anemia in patients with chronic kidney disease (CKD). Although the literature supports this practice, previous studies were limited by short treatment duration, lack of randomization, or absence of the approved three times per week (TIW) dosing arm. This randomized trial evaluated extended dosing regimens of epoetin alfa, comparing QW and Q2W to TIW dosing in anemic CKD subjects. The primary objective was to show that treatment with epoetin alfa at QW and Q2W intervals was not inferior to TIW dosing. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: 375 subjects with stage 3 to 4 CKD were randomized equally to the three groups and treated for 44 wk; to explore the impact of changing from TIW to QW administration on hemoglobin (Hb) control and adverse events, subjects on TIW switched to QW after 22 wk. The Hb was measured weekly, and the dose of epoetin alfa was adjusted to achieve and maintain an Hb level of 11.0 to 11.9 g/dl. RESULTS: Both the QW and Q2W regimens met the primary efficacy endpoint. More subjects in the TIW group than in the QW and Q2W groups exceeded the Hb ceiling. Adverse events were similar across treatment groups and consistent with the morbidities of CKD patients. CONCLUSIONS: Administration of epoetin alfa at QW and Q2W intervals are potential alternatives to TIW dosing for the treatment of anemia in stage 3 to 4 CKD subjects.
RCT Entities:
BACKGROUND AND OBJECTIVES: In clinical practice, physicians often use once-weekly (QW) and biweekly (Q2W) dosing of epoetin alfa to treat anemia in patients with chronic kidney disease (CKD). Although the literature supports this practice, previous studies were limited by short treatment duration, lack of randomization, or absence of the approved three times per week (TIW) dosing arm. This randomized trial evaluated extended dosing regimens of epoetin alfa, comparing QW and Q2W to TIW dosing in anemic CKD subjects. The primary objective was to show that treatment with epoetin alfa at QW and Q2W intervals was not inferior to TIW dosing. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: 375 subjects with stage 3 to 4 CKD were randomized equally to the three groups and treated for 44 wk; to explore the impact of changing from TIW to QW administration on hemoglobin (Hb) control and adverse events, subjects on TIW switched to QW after 22 wk. The Hb was measured weekly, and the dose of epoetin alfa was adjusted to achieve and maintain an Hb level of 11.0 to 11.9 g/dl. RESULTS: Both the QW and Q2W regimens met the primary efficacy endpoint. More subjects in the TIW group than in the QW and Q2W groups exceeded the Hb ceiling. Adverse events were similar across treatment groups and consistent with the morbidities of CKDpatients. CONCLUSIONS: Administration of epoetin alfa at QW and Q2W intervals are potential alternatives to TIW dosing for the treatment of anemia in stage 3 to 4 CKD subjects.
Authors: D S Silverberg; D Wexler; M Blum; G Keren; D Sheps; E Leibovitch; D Brosh; S Laniado; D Schwartz; T Yachnin; I Shapira; D Gavish; R Baruch; B Koifman; C Kaplan; S Steinbruch; A Iaina Journal: J Am Coll Cardiol Date: 2000-06 Impact factor: 24.094
Authors: Michael Germain; C Venkata Ram; Sarbani Bhaduri; K Linda Tang; Mark Klausner; Mario Curzi Journal: Nephrol Dial Transplant Date: 2005-06-28 Impact factor: 5.992
Authors: Iain C Macdougall; Rowan Walker; Robert Provenzano; Fernando de Alvaro; Harold R Locay; Paul C Nader; Francesco Locatelli; Frank C Dougherty; Ulrich Beyer Journal: Clin J Am Soc Nephrol Date: 2008-02-20 Impact factor: 8.237
Authors: Bruce Spinowitz; Michael Germain; Robert Benz; Marsha Wolfson; Tracy McGowan; K Linda Tang; Marc Kamin Journal: Clin J Am Soc Nephrol Date: 2008-04-09 Impact factor: 8.237
Authors: Deirdre Hahn; Christopher I Esezobor; Noha Elserafy; Angela C Webster; Elisabeth M Hodson Journal: Cochrane Database Syst Rev Date: 2017-01-09
Authors: Pablo E Pergola; Gary Gartenberg; Min Fu; Steven Sun; Marsha Wolfson; Peter Bowers Journal: Clin J Am Soc Nephrol Date: 2010-02-25 Impact factor: 8.237
Authors: Ioannis Koulouridis; Mansour Alfayez; Thomas A Trikalinos; Ethan M Balk; Bertrand L Jaber Journal: Am J Kidney Dis Date: 2012-08-22 Impact factor: 8.860
Authors: Javier Arrieta; Iñigo Moina; José Molina; Isabel Gallardo; María Luisa Muñiz; Carmen Robledo; Oscar García; Fernando Vidaur; Rosa Inés Muñoz; Izaskun Iribar; Román Aguirre; Antonio Maza Journal: Int J Nephrol Renovasc Dis Date: 2014-10-09
Authors: E H Fiocchi; L D Cowgill; D C Brown; J E Markovich; S Tucker; M A Labato; M B Callan Journal: J Vet Intern Med Date: 2017-03-03 Impact factor: 3.333