Efficacy of Intravenous Methoxy Polyethylene Glycol-Epoetin Beta Administered Every 2 Weeks Compared With Epoetin Administered 3 Times Weekly in Patients Treated by Hemodialysis or Peritoneal Dialysis: A Randomized Trial

Klinger, Marian; Arias, María Trinidad García; Vargemezis, Vassilis; Besarab, Anatole; Sułowicz, Władysław; Gerntholtz, Trevor; Ciechanowski, Kazimierz; Dougherty, Frank C.; Beyer, Ulrich

doi:10.1053/j.ajkd.2007.08.013

Cited by 67 publications

(67 citation statements)

References 27 publications

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“…It has also been reported that after anemia improves, CERA should be administered once every 4 weeks in the dose range of 25-250 μg to maintain the target Hb level. Reports show that the Hb level is maintained by administering CERA once every 2-4 weeks because of its long serum half-life [89][90][91][92][93][94]. However, the Maintenance of Haemoglobin Excels with IV Administration of CERA (MAXIMA) [90] and Patients Receiving CERA Once a Month for the Maintenance of Stable Hemoglobin (PROTOS) [91] studies, in which switching from rHuEPO to CERA in HD patients was examined in the form of RCTs, showed that an optimal Hb level, which is similar to the previous treatment with rHuEPO, was maintained by administering CERA once every 2 or 4 weeks but that the dose of CERA required to maintain an optimal Hb level once every 4 weeks was higher than that required once every 2 weeks.…”

Section: (2)target Hb Levels To Be Maintained In Pd Patientsmentioning

confidence: 99%

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

Yamamoto¹,

et al. 2017

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Section: (2)target Hb Levels To Be Maintained In Pd Patientsmentioning

confidence: 99%

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

Yamamoto¹,

et al. 2017

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“…8,[11][12][13][14][15][16][17][18][19][20][21][22] These studies have included patients who were or were not undergoing dialysis. In addition, the open-label, non-comparative (MIRACEL) study assessed the efficacy of MPG-EPO in a real-life situation.…”

Section: Therapeutic Efficacymentioning

confidence: 99%

Methoxy polyethylene glycol-epoetin beta for anemia with chronic kidney disease

Ohashi¹,

Sakao²,

Yasuda³

et al. 2012

IJNRD

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Chronic kidney disease (CKD) is a risk factor for end-stage renal failure and cardiovascular events. In patients with CKD, anemia is often caused by decreased erythropoietin production relative to hemoglobin levels. As correction of anemia is associated with improved cardiac and renal function and quality of life, erythropoiesis-stimulating agents (ESAs) are standard therapy for anemia in CKD patients. However, traditional ESAs such as epoetin or darbepoetin have short half-lives and require frequent administration, dose changes, and close monitoring of hemoglobin concentration to maintain target hemoglobin levels. Methoxy polyethylene glycol-epoetin beta (MPG-EPO) is the only ESA that is generated by chemical modification of glycosylated erythropoietin through the integration of one specific, long, linear chain of polyethylene glycol. This ESA induces continuous erythropoietin receptor activation and has a long half-life (approximately 130 hours). Subcutaneous or intravenous administration of MPG-EPO once every 2 weeks or monthly achieved a high hemoglobin response rate in patients with anemia associated with CKD, regardless of whether the patient was undergoing dialysis. According to data from an observational time and motion study, MPG-EPO maintains hemoglobin levels when the same dose is administered, however infrequently. This suggests that compared with the use of traditional ESAs, administration of MPG-EPO reduces the overall time and cost associated with the management of anemia in CKD patients undergoing dialysis. MPG-EPO is generally well tolerated and most adverse events are of mild to moderate severity. The most commonly reported adverse effects are hypertension, nasopharyngitis, and diarrhea. Subcutaneous injection of MPG-EPO is significantly less painful than subcutaneous injection of darbepoetin. In conclusion, MPG-EPO is as effective and safe as traditional ESAs in managing renal anemia, irrespective of whether the patient is undergoing dialysis.

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“…The trial program for methoxy polyethylene glycol-epoetin beta included some PD patients in specific trials, but the patient populations were always heterogeneous-that is, they included both HD and PD patients (21,22).…”

Section: Discussionmentioning

confidence: 99%

Peginesatide to Manage Anemia in Chronic Kidney Disease Patients on Peritoneal Dialysis

Zabaneh¹,

Roger

El-Shahawy

et al. 2015

Perit Dial Int

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♦ Background: Peginesatide is a novel, synthetic, peptidebased pegylated erythropoiesis-stimulating agent that is designed specifically to stimulate the erythropoietin receptor. The purpose of the present study was to assess, for the first time, the efficacy and safety of peginesatide in chronic kidney disease (CKD) patients receiving peritoneal dialysis (PD) and previously on epoetin treatment. ♦ Methods: In this open-label multicenter study, 59 PD patients with CKD were converted from epoetin (alfa or beta) to once-monthly peginesatide. Doses were titrated to maintain hemoglobin levels between 10 g/dL and 12 g/dL during the 25 weeks of the study. The primary endpoint was change from baseline in mean hemoglobin values during the evaluation period (weeks 20 -25). ♦ Results: The mean hemoglobin value during the evaluation period was 11.3 ± 1.07 g/dL, and the mean change from baseline was 0.10 ± 1.15 g/dL (95% confidence limits: -0.24, 0.44 g/dL). During the evaluation period, most patients maintained hemoglobin levels between 10 g/dL and 12 g/dL (63.0%) and within ±1.0 g/dL of baseline (60.9%). The median weekly epoetin dose at baseline was 96.0 U/kg, and the median starting peginesatide dose was 0.047 mg/kg. Forty-three patients (72.9%) completed the study. Six patients (10.2%) received red blood cell transfusions. The observed adverse event profile was consistent with underlying conditions in the PD patient population. The most common adverse event was peritonitis (20.3%), a complication commonly associated with PD. Four deaths occurred during the study (2 related to septic shock, and 1 each to myocardial ischemia and myasthenia gravis). ♦ Conclusions: In this study, once-monthly peginesatide maintained hemoglobin levels in PD patients after conversion from epoetin.

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Efficacy of Intravenous Methoxy Polyethylene Glycol-Epoetin Beta Administered Every 2 Weeks Compared With Epoetin Administered 3 Times Weekly in Patients Treated by Hemodialysis or Peritoneal Dialysis: A Randomized Trial

Cited by 67 publications

References 27 publications

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

Methoxy polyethylene glycol-epoetin beta for anemia with chronic kidney disease

Peginesatide to Manage Anemia in Chronic Kidney Disease Patients on Peritoneal Dialysis

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