Effect of Haemoglobin (Hb) Maintenance of Subcutaneous (SC) or Intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in Renal Anemia Patients on Peritoneal Dialysis

Makoto Hiramatsu, Osamu Hotta, Ikuto Masakane, Hiromichi Suzuki, Takahiro Mochizuki, Yoshiko Nishizawa, Hiroki Maruyama, Yukio Yuzawa, Hiroaki Asada, Daijo Inaguma, Hirotake Kasuga, Enyu Imai, Terumasa Hayashi, Tsutomu Tabata, Yoshihiko Saito, Hideki Kawanishi, Jun Minakuchi, Kazuhito Takeda, Tahei Yanagida, Masahiko NakamotoMichiya Shinozaki, Izumi Shimano, Masami Bessho, Masashi Suzuki

Research output: Contribution to journalArticle

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Abstract

Background: C. E. R. A., a continuous erythropoietin receptor activator, is currently under clinical development for the treatment of anemia at extended administration intervals. In the present study, we evaluated the therapeutic and safety profiles of C. E. R. A. after either SC or IV administration at a dosing interval of once every 4 weeks (Q4W) to renal anemia patients on peritoneal dialysis previously treated with rHuEPO. Methods: Renal anemia patients (n = 63) on peritoneal dialysis were assigned to one of the two treatment groups depending upon the previous rHuEPO doses administered. Patients who had received<4500 IU/wk rHuEPO were assigned to the 100 μg C. E. R. A. group, and those who had received ≧4500 IU/wk were assigned to receive 150 μg C. E. R. A. group. C. E. R. A. was administered Q4W via either SC (n = 35) or IV (n = 28) routes. After the 8-week switching period, the doses of C. E. R. A. Q4W were administered with dose adjustment rang-ing from 25 to 400 μg to maintain haemoglobin (Hb) levels of 10-12 g/dL during the 40-week maintenance period. Primary endpoint was the percentage of patients whose mean Hb maintained within the target Hb levels during 18-24 weeks. Results: C. E. R. A. Q4W administered successfully maintained the target Hb levels 61.9% during 18-24 weeks. A total of 88.9% of the pts successfully maintained these levels at 48 weeks. Furthermore, no significant differences in the maintenance rate were found between SC and IV routes of administration. Adverse event profiles were found to be similar between the two administration routes, and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. Q4W switching after a previous rHuEPO was adequate to maintain the target Hb levels, regardless of administration route (both SC and IV), therefore, is an effective treatment for the maintenance of Hb levels in peritoneal dialysis pts.

Original languageEnglish
JournalJapanese Pharmacology and Therapeutics
Volume39
Issue numberSUPPL. 1
Publication statusPublished - 10-05-2011

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Peritoneal Dialysis
Anemia
Hemoglobins
Maintenance
Kidney
Intravenous Administration
Therapeutics
continuous erythropoietin receptor activator
Safety
Antibodies

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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Hiramatsu, Makoto ; Hotta, Osamu ; Masakane, Ikuto ; Suzuki, Hiromichi ; Mochizuki, Takahiro ; Nishizawa, Yoshiko ; Maruyama, Hiroki ; Yuzawa, Yukio ; Asada, Hiroaki ; Inaguma, Daijo ; Kasuga, Hirotake ; Imai, Enyu ; Hayashi, Terumasa ; Tabata, Tsutomu ; Saito, Yoshihiko ; Kawanishi, Hideki ; Minakuchi, Jun ; Takeda, Kazuhito ; Yanagida, Tahei ; Nakamoto, Masahiko ; Shinozaki, Michiya ; Shimano, Izumi ; Bessho, Masami ; Suzuki, Masashi. / Effect of Haemoglobin (Hb) Maintenance of Subcutaneous (SC) or Intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in Renal Anemia Patients on Peritoneal Dialysis. In: Japanese Pharmacology and Therapeutics. 2011 ; Vol. 39, No. SUPPL. 1.
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abstract = "Background: C. E. R. A., a continuous erythropoietin receptor activator, is currently under clinical development for the treatment of anemia at extended administration intervals. In the present study, we evaluated the therapeutic and safety profiles of C. E. R. A. after either SC or IV administration at a dosing interval of once every 4 weeks (Q4W) to renal anemia patients on peritoneal dialysis previously treated with rHuEPO. Methods: Renal anemia patients (n = 63) on peritoneal dialysis were assigned to one of the two treatment groups depending upon the previous rHuEPO doses administered. Patients who had received<4500 IU/wk rHuEPO were assigned to the 100 μg C. E. R. A. group, and those who had received ≧4500 IU/wk were assigned to receive 150 μg C. E. R. A. group. C. E. R. A. was administered Q4W via either SC (n = 35) or IV (n = 28) routes. After the 8-week switching period, the doses of C. E. R. A. Q4W were administered with dose adjustment rang-ing from 25 to 400 μg to maintain haemoglobin (Hb) levels of 10-12 g/dL during the 40-week maintenance period. Primary endpoint was the percentage of patients whose mean Hb maintained within the target Hb levels during 18-24 weeks. Results: C. E. R. A. Q4W administered successfully maintained the target Hb levels 61.9{\%} during 18-24 weeks. A total of 88.9{\%} of the pts successfully maintained these levels at 48 weeks. Furthermore, no significant differences in the maintenance rate were found between SC and IV routes of administration. Adverse event profiles were found to be similar between the two administration routes, and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. Q4W switching after a previous rHuEPO was adequate to maintain the target Hb levels, regardless of administration route (both SC and IV), therefore, is an effective treatment for the maintenance of Hb levels in peritoneal dialysis pts.",
author = "Makoto Hiramatsu and Osamu Hotta and Ikuto Masakane and Hiromichi Suzuki and Takahiro Mochizuki and Yoshiko Nishizawa and Hiroki Maruyama and Yukio Yuzawa and Hiroaki Asada and Daijo Inaguma and Hirotake Kasuga and Enyu Imai and Terumasa Hayashi and Tsutomu Tabata and Yoshihiko Saito and Hideki Kawanishi and Jun Minakuchi and Kazuhito Takeda and Tahei Yanagida and Masahiko Nakamoto and Michiya Shinozaki and Izumi Shimano and Masami Bessho and Masashi Suzuki",
year = "2011",
month = "5",
day = "10",
language = "English",
volume = "39",
journal = "Japanese Pharmacology and Therapeutics",
issn = "0386-3603",
publisher = "Life Science Publishing Co. Ltd",
number = "SUPPL. 1",

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Hiramatsu, M, Hotta, O, Masakane, I, Suzuki, H, Mochizuki, T, Nishizawa, Y, Maruyama, H, Yuzawa, Y, Asada, H, Inaguma, D, Kasuga, H, Imai, E, Hayashi, T, Tabata, T, Saito, Y, Kawanishi, H, Minakuchi, J, Takeda, K, Yanagida, T, Nakamoto, M, Shinozaki, M, Shimano, I, Bessho, M & Suzuki, M 2011, 'Effect of Haemoglobin (Hb) Maintenance of Subcutaneous (SC) or Intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in Renal Anemia Patients on Peritoneal Dialysis', Japanese Pharmacology and Therapeutics, vol. 39, no. SUPPL. 1.

Effect of Haemoglobin (Hb) Maintenance of Subcutaneous (SC) or Intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in Renal Anemia Patients on Peritoneal Dialysis. / Hiramatsu, Makoto; Hotta, Osamu; Masakane, Ikuto; Suzuki, Hiromichi; Mochizuki, Takahiro; Nishizawa, Yoshiko; Maruyama, Hiroki; Yuzawa, Yukio; Asada, Hiroaki; Inaguma, Daijo; Kasuga, Hirotake; Imai, Enyu; Hayashi, Terumasa; Tabata, Tsutomu; Saito, Yoshihiko; Kawanishi, Hideki; Minakuchi, Jun; Takeda, Kazuhito; Yanagida, Tahei; Nakamoto, Masahiko; Shinozaki, Michiya; Shimano, Izumi; Bessho, Masami; Suzuki, Masashi.

In: Japanese Pharmacology and Therapeutics, Vol. 39, No. SUPPL. 1, 10.05.2011.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effect of Haemoglobin (Hb) Maintenance of Subcutaneous (SC) or Intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in Renal Anemia Patients on Peritoneal Dialysis

AU - Hiramatsu, Makoto

AU - Hotta, Osamu

AU - Masakane, Ikuto

AU - Suzuki, Hiromichi

AU - Mochizuki, Takahiro

AU - Nishizawa, Yoshiko

AU - Maruyama, Hiroki

AU - Yuzawa, Yukio

AU - Asada, Hiroaki

AU - Inaguma, Daijo

AU - Kasuga, Hirotake

AU - Imai, Enyu

AU - Hayashi, Terumasa

AU - Tabata, Tsutomu

AU - Saito, Yoshihiko

AU - Kawanishi, Hideki

AU - Minakuchi, Jun

AU - Takeda, Kazuhito

AU - Yanagida, Tahei

AU - Nakamoto, Masahiko

AU - Shinozaki, Michiya

AU - Shimano, Izumi

AU - Bessho, Masami

AU - Suzuki, Masashi

PY - 2011/5/10

Y1 - 2011/5/10

N2 - Background: C. E. R. A., a continuous erythropoietin receptor activator, is currently under clinical development for the treatment of anemia at extended administration intervals. In the present study, we evaluated the therapeutic and safety profiles of C. E. R. A. after either SC or IV administration at a dosing interval of once every 4 weeks (Q4W) to renal anemia patients on peritoneal dialysis previously treated with rHuEPO. Methods: Renal anemia patients (n = 63) on peritoneal dialysis were assigned to one of the two treatment groups depending upon the previous rHuEPO doses administered. Patients who had received<4500 IU/wk rHuEPO were assigned to the 100 μg C. E. R. A. group, and those who had received ≧4500 IU/wk were assigned to receive 150 μg C. E. R. A. group. C. E. R. A. was administered Q4W via either SC (n = 35) or IV (n = 28) routes. After the 8-week switching period, the doses of C. E. R. A. Q4W were administered with dose adjustment rang-ing from 25 to 400 μg to maintain haemoglobin (Hb) levels of 10-12 g/dL during the 40-week maintenance period. Primary endpoint was the percentage of patients whose mean Hb maintained within the target Hb levels during 18-24 weeks. Results: C. E. R. A. Q4W administered successfully maintained the target Hb levels 61.9% during 18-24 weeks. A total of 88.9% of the pts successfully maintained these levels at 48 weeks. Furthermore, no significant differences in the maintenance rate were found between SC and IV routes of administration. Adverse event profiles were found to be similar between the two administration routes, and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. Q4W switching after a previous rHuEPO was adequate to maintain the target Hb levels, regardless of administration route (both SC and IV), therefore, is an effective treatment for the maintenance of Hb levels in peritoneal dialysis pts.

AB - Background: C. E. R. A., a continuous erythropoietin receptor activator, is currently under clinical development for the treatment of anemia at extended administration intervals. In the present study, we evaluated the therapeutic and safety profiles of C. E. R. A. after either SC or IV administration at a dosing interval of once every 4 weeks (Q4W) to renal anemia patients on peritoneal dialysis previously treated with rHuEPO. Methods: Renal anemia patients (n = 63) on peritoneal dialysis were assigned to one of the two treatment groups depending upon the previous rHuEPO doses administered. Patients who had received<4500 IU/wk rHuEPO were assigned to the 100 μg C. E. R. A. group, and those who had received ≧4500 IU/wk were assigned to receive 150 μg C. E. R. A. group. C. E. R. A. was administered Q4W via either SC (n = 35) or IV (n = 28) routes. After the 8-week switching period, the doses of C. E. R. A. Q4W were administered with dose adjustment rang-ing from 25 to 400 μg to maintain haemoglobin (Hb) levels of 10-12 g/dL during the 40-week maintenance period. Primary endpoint was the percentage of patients whose mean Hb maintained within the target Hb levels during 18-24 weeks. Results: C. E. R. A. Q4W administered successfully maintained the target Hb levels 61.9% during 18-24 weeks. A total of 88.9% of the pts successfully maintained these levels at 48 weeks. Furthermore, no significant differences in the maintenance rate were found between SC and IV routes of administration. Adverse event profiles were found to be similar between the two administration routes, and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. Q4W switching after a previous rHuEPO was adequate to maintain the target Hb levels, regardless of administration route (both SC and IV), therefore, is an effective treatment for the maintenance of Hb levels in peritoneal dialysis pts.

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