C.E.R.A. Corrects Anemia in Patients with Chronic Kidney Disease not on Dialysis

Macdougall, Iain C.; Walker, Rowan G.; Provenzano, Robert; Álvaro, Fernando de; Locay, Harold R.; Nader, Paul; Locatelli, Francesco; Dougherty, Frank C.; Beyer, Ulrich

doi:10.2215/cjn.00480107

Cited by 95 publications

(82 citation statements)

References 20 publications

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“…An increased risk of TVEs has been reported in some patient populations treated with ESAs (23,24). In this study, the incidence of TVEs was low, despite the fact that many subjects had multiple preexisting risk factors (age, diabetes mellitus, hypertension, hypercholesterolemia, obesity, and prior history of vascular events).…”

Section: Discussionmentioning

confidence: 62%

A Randomized Controlled Study Comparing Once-Weekly to Every-2-Week and Every-4-Week Dosing of Epoetin Alfa in CKD Patients with Anemia

Pèrgola¹,

Gartenberg²,

Fu³

et al. 2010

Clinical Journal of the American Society of Nephrology

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Background and objectives: Extended-interval dosing of epoetin alfa (EPO) is commonly used to treat anemia in patients with chronic kidney disease (CKD).This study aimed to demonstrate that EPO dosed every 2 weeks (Q2W) and every 4 weeks (Q4W) was noninferior to once-weekly (QW) dosing.Design, setting, participants, & measurements: 430 anemic subjects with stage 3 to 4 CKD receiving a stable QW dose of EPO were randomized 1:1:2 to QW, Q2W, and Q4W dosing for 36 weeks. Hemoglobin (Hb) was measured weekly, and the dose of EPO was adjusted to maintain an Hb level of 11.0 to 11.9 g/dl. The primary endpoint was change in Hb from baseline to the average of the last 12 weeks of treatment.Results: Both the Q2W and Q4W dosing groups were noninferior to the QW group. The estimated difference of the mean change in Hb between Q2W and QW was ؊0.03 g/dl; and between Q4W and QW was ؊0.09 g/dl. From weeks 13 to 37, the mean percentage of weeks per subject with Hb 10.0 to 11.9 g/dl, inclusive, was 81% for QW, 81% for Q2W, and 75% for Q4W. Death occurred, respectively, in 4%, 3%, and 4%; thromboembolic vascular events occurred in 3%, 5%, and 3%; and serious adverse events occurred in 22%, 26%, and 26% of subjects.Conclusions: Q2W and Q4W EPO dosing maintained Hb levels in subjects with stage 3 to 4 CKD. Deaths, thromboembolic vascular events, and serious adverse events were comparable across the dosing groups.

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Section: Discussionmentioning

confidence: 62%

A Randomized Controlled Study Comparing Once-Weekly to Every-2-Week and Every-4-Week Dosing of Epoetin Alfa in CKD Patients with Anemia

Pèrgola¹,

Gartenberg²,

Fu³

et al. 2010

Clinical Journal of the American Society of Nephrology

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“…Hypertension was similar in Epo and darbepoetin arms in both trials (65,66). Not surprisingly, similar hypertensive effects in predialysis patients have been reported for pharmacologic administration of the newer ESA agents, pegylated Epo and hematide, which share Epo's mechanism of activating the Epo receptor (67,68).…”

Section: No Difference In Bp Response Between Darbepoetin or Epo In Pmentioning

confidence: 57%

Arterial Hypertension Induced by Erythropoietin and Erythropoiesis-Stimulating Agents (ESA)

Krapf¹,

Hulter²

2009

Clinical Journal of the American Society of Nephrology

161

118

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This review summarizes the evidence for a hypertensinogenic effect of Erythropoietin (Epo) in normal human subjects and predialysis, hemodialysis, and continuous ambulatory peritoneal dialysis (CAPD) patients. The possible mechanisms of Epo-induced hypertension are examined with in vivo animal and in vitro data, as well as pathophysiological human studies in both normal subjects and CKD patients. The evidence for a hypertensinogenic effect of erythropoiesis-stimulating agents (ESAs) in normal subjects, predialysis CKD, hemodialysis, and CAPD patients is compelling. Epo increases BP directly and notably independently of its erythropoietic effect and its effect on blood rheology. The potential for the development of future agents that might act as specific stimulators of erythropoiesis, devoid of direct hemodynamic side effects is underscored.

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“…An increased risk of TVEs has been reported in some patient populations treated with ESAs (22,23), most notably in oncology patients and in patients undergoing surgical procedures. In this study, the incidence of TVEs was low, despite the fact that these subjects had multiple pre-existing risk factors (age, diabetes mellitus, hypertension, hypercholesterolemia, obesity, and prior history of vascular events).…”

Section: Discussionmentioning

confidence: 99%

A Randomized Controlled Study of Weekly and Biweekly Dosing of Epoetin Alfa in CKD Patients With Anemia

Pèrgola

Gartenberg

et al. 2009

Clinical Journal of the American Society of Nephrology

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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.

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C.E.R.A. Corrects Anemia in Patients with Chronic Kidney Disease not on Dialysis

Cited by 95 publications

References 20 publications

A Randomized Controlled Study Comparing Once-Weekly to Every-2-Week and Every-4-Week Dosing of Epoetin Alfa in CKD Patients with Anemia

A Randomized Controlled Study Comparing Once-Weekly to Every-2-Week and Every-4-Week Dosing of Epoetin Alfa in CKD Patients with Anemia

Arterial Hypertension Induced by Erythropoietin and Erythropoiesis-Stimulating Agents (ESA)

A Randomized Controlled Study of Weekly and Biweekly Dosing of Epoetin Alfa in CKD Patients With Anemia

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