Comparison of the effects of weekly and biweekly intravenous CERA administration on erythropoiesis: A randomized controlled trial

Although continuous erythropoietin receptor activators (CERAs) are widely used erythropoiesis‐stimulating agents for correcting renal anemia in patients undergoing hemodialysis (HD), few reports have examined weekly CERA administration. In this randomized controlled trial, we compared the efficacy and changes in the parameters of iron metabolism and erythropoiesis between weekly and biweekly CERA administration. In total, 120 patients undergoing maintenance HD were randomized to the weekly or biweekly group. The primary end point was the total CERA dose needed to maintain the target hemoglobin (Hb) levels during a 12‐week evaluation period. There was no significant difference in the total dose between the weekly and biweekly groups (median 175.0 [interquartile range (IQR) 93.8–337.5] µg/12 weeks vs. 300.0 [IQR 125.0–375.0] µg/12 weeks, P = .18). The mean Hb levels during the evaluation period were 10.9 ± 0.8 g/dL in the weekly group and 10.7 ± 0.8 g/dL in the biweekly group (P = .25). Weekly CERA administration was well tolerated. Weekly CERA administration similarly managed anemia as biweekly administration in patients undergoing HD.

[1]  A. Fujimori,et al.  Twice‐Monthly Administration of a Lower Dose of Epoetin Beta Pegol Can Maintain Adequate Hemoglobin Levels in Hemodialysis Patients , 2015, Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy.

[2]  Y. Toya,et al.  Acceleration of Iron Utilization After Intravenous Iron Administration During Activated Erythropoiesis in Hemodialysis Patients: A Randomized Study , 2015, Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy.

[3]  K. Kitamura,et al.  A Randomized Control Study on the Procedure for Switching Epoetin Beta (EPO) to Epoetin Beta Pegol (CERA) in the Treatment of Renal Anemia in Maintenance Hemodialysis Patients , 2014, Blood Purification.

[4]  A. Fujimori,et al.  Comparison of 2‐Week Versus 4‐Week Dosing Intervals of Epoetin Beta Pegol on Erythropoiesis and Iron Metabolism in Hemodialysis Patients , 2014, Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy.

[5]  Y. Toya,et al.  Changes in Hepcidin and Reticulocyte Hemoglobin Equivalent Levels in Response to Continuous Erythropoietin Receptor Activator Administration in Hemodialysis Patients: A Randomized Study , 2014, Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy.

[6]  J. Adamson,et al.  Notice , 2012, Kidney International Supplements.

[7]  J. Adamson,et al.  KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease , 2012 .

[8]  Y. Aso,et al.  Simple and sensitive quantification of bioactive peptides in biological matrices using liquid chromatography/selected reaction monitoring mass spectrometry coupled with trichloroacetic acid clean-up. , 2007, Rapid communications in mass spectrometry : RCM.

[9]  N. Levin,et al.  Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA) , 2007, The Lancet.

[10]  F. Locatelli,et al.  Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. , 2007, Clinical journal of the American Society of Nephrology : CJASN.

[11]  F. C. Dougherty,et al.  Pharmacokinetics and pharmacodynamics of intravenous and subcutaneous continuous erythropoietin receptor activator (C.E.R.A.) in patients with chronic kidney disease. , 2006, Clinical journal of the American Society of Nephrology : CJASN.

[12]  I. Macdougall,et al.  Novel strategies for stimulating erythropoiesis and potential new treatments for anaemia , 2006, The Lancet.

[13]  J. Linssen,et al.  Reticulocyte hemoglobin measurement – comparison of two methods in the diagnosis of iron-restricted erythropoiesis , 2005, Clinical chemistry and laboratory medicine.

[14]  Jerry Kaplan,et al.  Hepcidin Regulates Cellular Iron Efflux by Binding to Ferroportin and Inducing Its Internalization , 2004, Science.

[15]  Francesco Locatelli,et al.  Anemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). , 2004, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[16]  R. Foley,et al.  Anemia, hospitalization, and mortality in patients receiving peritoneal dialysis in the United States. , 2004, Kidney international.

[17]  F. Locatelli,et al.  Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. , 2004, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[18]  Tomas Ganz,et al.  Hepcidin, a key regulator of iron metabolism and mediator of anemia of inflammation. , 2003, Blood.

[19]  Bruno Turlin,et al.  A New Mouse Liver-specific Gene, Encoding a Protein Homologous to Human Antimicrobial Peptide Hepcidin, Is Overexpressed during Iron Overload* , 2001, The Journal of Biological Chemistry.

[20]  B. Skikne,et al.  Erythropoietin, iron, and erythropoiesis. , 2000, Blood.

[21]  W. Owen,et al.  Anemia in hemodialysis patients: variables affecting this outcome predictor. , 1997, Journal of the American Society of Nephrology : JASN.

[22]  S. Fishbane,et al.  Reticulocyte hemoglobin content in the evaluation of iron status of hemodialysis patients. , 1997, Kidney international.