Clinical efficacies of C. E. R. A. (Continuous Erythropoietin Receptor Activator) administered intravenously to epoetin (EPO) naïve renal anemia patients on hemodialysis - Phase III study

Yuzo Watanabe, Noritomo Itami, Nobuo Hashimoto, Akira Kurosawa, Kazue Ueki, Yasufumi Irie, Ryoichi Ando, Hisao Muto, Yutaka Kanno, Chikao Yamazaki, Akira Ito, Hiroshi Ogawa, Tomohiko Naruse, Daijo Inaguma, Hirotake Kasuga, Katsushi Koyama, Takashi Sato, Toshihiko Ono, Yasushi Saika, Munesuke MatsumotoMasafumi Taki, Masaki Fukushima, Jun Minakuchi, Kenji Yuasa, Susumu Miyake, Kazuhito Takeda, Akiyo Shiroozu, Seiya Okuda, Masahiko Nakamoto, Kei Hori, Kenichi Fukunari, Masami Bessho, Masashi Suzuki

Research output: Contribution to journalArticle

Abstract

Background: This study was designed to examine the clinical effects of C. E. R. A., a continuous erythropoietin receptor activator, administered intravenously (i. v.) at a dose level of 50 μg once every 2 weeks to EPO naïve renal anemia patients on hemodialysis. Methods: EPO naïve renal anemia patients were treated with C. E. R. A. i. v. at 50 μg once every 2 weeks during the correction period of anemia in order to attain the Hb levels of above 11 g/dL. The observation period established was 24 weeks, and the primary endpoint investigated was the percentage of patients who achieved the Hb levels of above 10 g/dL and the delta (Δ) Hb levels of 1 g/dL from baseline. Results: The Hb levels of renal anemia patients treated with C. E. R. A. were successfully corrected above 11 g/dL. The percentage of patients who attained Hb levels of above 10 g/ dL and the Δ Hb levels of above 1 g/dL from baseline was found to be 91.7%. It was shown from the present study, moreover, that the safety profiles of C. E. R. A. were similar to those of existing ESAs, erythropoiesis stimulating agents, and that the antibodies against C. E. R. A. were not detected in all the patients examined. Conclusions: This study has firstly disclosed that the administrations of C. E. R. A. i. v. at a dose level of 50 μg once every 2 weeks provided smooth as well as gradual increases of the Hb levels in patients with renal anemia on hemodialysis.

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

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Renal Dialysis
Anemia
Kidney
Hematinics
continuous erythropoietin receptor activator
Observation
Safety
Antibodies

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Watanabe, Yuzo ; Itami, Noritomo ; Hashimoto, Nobuo ; Kurosawa, Akira ; Ueki, Kazue ; Irie, Yasufumi ; Ando, Ryoichi ; Muto, Hisao ; Kanno, Yutaka ; Yamazaki, Chikao ; Ito, Akira ; Ogawa, Hiroshi ; Naruse, Tomohiko ; Inaguma, Daijo ; Kasuga, Hirotake ; Koyama, Katsushi ; Sato, Takashi ; Ono, Toshihiko ; Saika, Yasushi ; Matsumoto, Munesuke ; Taki, Masafumi ; Fukushima, Masaki ; Minakuchi, Jun ; Yuasa, Kenji ; Miyake, Susumu ; Takeda, Kazuhito ; Shiroozu, Akiyo ; Okuda, Seiya ; Nakamoto, Masahiko ; Hori, Kei ; Fukunari, Kenichi ; Bessho, Masami ; Suzuki, Masashi. / Clinical efficacies of C. E. R. A. (Continuous Erythropoietin Receptor Activator) administered intravenously to epoetin (EPO) naïve renal anemia patients on hemodialysis - Phase III study. In: Japanese Pharmacology and Therapeutics. 2011 ; Vol. 39, No. SUPPL. 1.
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title = "Clinical efficacies of C. E. R. A. (Continuous Erythropoietin Receptor Activator) administered intravenously to epoetin (EPO) na{\"i}ve renal anemia patients on hemodialysis - Phase III study",
abstract = "Background: This study was designed to examine the clinical effects of C. E. R. A., a continuous erythropoietin receptor activator, administered intravenously (i. v.) at a dose level of 50 μg once every 2 weeks to EPO na{\"i}ve renal anemia patients on hemodialysis. Methods: EPO na{\"i}ve renal anemia patients were treated with C. E. R. A. i. v. at 50 μg once every 2 weeks during the correction period of anemia in order to attain the Hb levels of above 11 g/dL. The observation period established was 24 weeks, and the primary endpoint investigated was the percentage of patients who achieved the Hb levels of above 10 g/dL and the delta (Δ) Hb levels of 1 g/dL from baseline. Results: The Hb levels of renal anemia patients treated with C. E. R. A. were successfully corrected above 11 g/dL. The percentage of patients who attained Hb levels of above 10 g/ dL and the Δ Hb levels of above 1 g/dL from baseline was found to be 91.7{\%}. It was shown from the present study, moreover, that the safety profiles of C. E. R. A. were similar to those of existing ESAs, erythropoiesis stimulating agents, and that the antibodies against C. E. R. A. were not detected in all the patients examined. Conclusions: This study has firstly disclosed that the administrations of C. E. R. A. i. v. at a dose level of 50 μg once every 2 weeks provided smooth as well as gradual increases of the Hb levels in patients with renal anemia on hemodialysis.",
author = "Yuzo Watanabe and Noritomo Itami and Nobuo Hashimoto and Akira Kurosawa and Kazue Ueki and Yasufumi Irie and Ryoichi Ando and Hisao Muto and Yutaka Kanno and Chikao Yamazaki and Akira Ito and Hiroshi Ogawa and Tomohiko Naruse and Daijo Inaguma and Hirotake Kasuga and Katsushi Koyama and Takashi Sato and Toshihiko Ono and Yasushi Saika and Munesuke Matsumoto and Masafumi Taki and Masaki Fukushima and Jun Minakuchi and Kenji Yuasa and Susumu Miyake and Kazuhito Takeda and Akiyo Shiroozu and Seiya Okuda and Masahiko Nakamoto and Kei Hori and Kenichi Fukunari and Masami Bessho and Masashi Suzuki",
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Watanabe, Y, Itami, N, Hashimoto, N, Kurosawa, A, Ueki, K, Irie, Y, Ando, R, Muto, H, Kanno, Y, Yamazaki, C, Ito, A, Ogawa, H, Naruse, T, Inaguma, D, Kasuga, H, Koyama, K, Sato, T, Ono, T, Saika, Y, Matsumoto, M, Taki, M, Fukushima, M, Minakuchi, J, Yuasa, K, Miyake, S, Takeda, K, Shiroozu, A, Okuda, S, Nakamoto, M, Hori, K, Fukunari, K, Bessho, M & Suzuki, M 2011, 'Clinical efficacies of C. E. R. A. (Continuous Erythropoietin Receptor Activator) administered intravenously to epoetin (EPO) naïve renal anemia patients on hemodialysis - Phase III study', Japanese Pharmacology and Therapeutics, vol. 39, no. SUPPL. 1.

Clinical efficacies of C. E. R. A. (Continuous Erythropoietin Receptor Activator) administered intravenously to epoetin (EPO) naïve renal anemia patients on hemodialysis - Phase III study. / Watanabe, Yuzo; Itami, Noritomo; Hashimoto, Nobuo; Kurosawa, Akira; Ueki, Kazue; Irie, Yasufumi; Ando, Ryoichi; Muto, Hisao; Kanno, Yutaka; Yamazaki, Chikao; Ito, Akira; Ogawa, Hiroshi; Naruse, Tomohiko; Inaguma, Daijo; Kasuga, Hirotake; Koyama, Katsushi; Sato, Takashi; Ono, Toshihiko; Saika, Yasushi; Matsumoto, Munesuke; Taki, Masafumi; Fukushima, Masaki; Minakuchi, Jun; Yuasa, Kenji; Miyake, Susumu; Takeda, Kazuhito; Shiroozu, Akiyo; Okuda, Seiya; Nakamoto, Masahiko; Hori, Kei; Fukunari, Kenichi; 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 - Clinical efficacies of C. E. R. A. (Continuous Erythropoietin Receptor Activator) administered intravenously to epoetin (EPO) naïve renal anemia patients on hemodialysis - Phase III study

AU - Watanabe, Yuzo

AU - Itami, Noritomo

AU - Hashimoto, Nobuo

AU - Kurosawa, Akira

AU - Ueki, Kazue

AU - Irie, Yasufumi

AU - Ando, Ryoichi

AU - Muto, Hisao

AU - Kanno, Yutaka

AU - Yamazaki, Chikao

AU - Ito, Akira

AU - Ogawa, Hiroshi

AU - Naruse, Tomohiko

AU - Inaguma, Daijo

AU - Kasuga, Hirotake

AU - Koyama, Katsushi

AU - Sato, Takashi

AU - Ono, Toshihiko

AU - Saika, Yasushi

AU - Matsumoto, Munesuke

AU - Taki, Masafumi

AU - Fukushima, Masaki

AU - Minakuchi, Jun

AU - Yuasa, Kenji

AU - Miyake, Susumu

AU - Takeda, Kazuhito

AU - Shiroozu, Akiyo

AU - Okuda, Seiya

AU - Nakamoto, Masahiko

AU - Hori, Kei

AU - Fukunari, Kenichi

AU - Bessho, Masami

AU - Suzuki, Masashi

PY - 2011/5/10

Y1 - 2011/5/10

N2 - Background: This study was designed to examine the clinical effects of C. E. R. A., a continuous erythropoietin receptor activator, administered intravenously (i. v.) at a dose level of 50 μg once every 2 weeks to EPO naïve renal anemia patients on hemodialysis. Methods: EPO naïve renal anemia patients were treated with C. E. R. A. i. v. at 50 μg once every 2 weeks during the correction period of anemia in order to attain the Hb levels of above 11 g/dL. The observation period established was 24 weeks, and the primary endpoint investigated was the percentage of patients who achieved the Hb levels of above 10 g/dL and the delta (Δ) Hb levels of 1 g/dL from baseline. Results: The Hb levels of renal anemia patients treated with C. E. R. A. were successfully corrected above 11 g/dL. The percentage of patients who attained Hb levels of above 10 g/ dL and the Δ Hb levels of above 1 g/dL from baseline was found to be 91.7%. It was shown from the present study, moreover, that the safety profiles of C. E. R. A. were similar to those of existing ESAs, erythropoiesis stimulating agents, and that the antibodies against C. E. R. A. were not detected in all the patients examined. Conclusions: This study has firstly disclosed that the administrations of C. E. R. A. i. v. at a dose level of 50 μg once every 2 weeks provided smooth as well as gradual increases of the Hb levels in patients with renal anemia on hemodialysis.

AB - Background: This study was designed to examine the clinical effects of C. E. R. A., a continuous erythropoietin receptor activator, administered intravenously (i. v.) at a dose level of 50 μg once every 2 weeks to EPO naïve renal anemia patients on hemodialysis. Methods: EPO naïve renal anemia patients were treated with C. E. R. A. i. v. at 50 μg once every 2 weeks during the correction period of anemia in order to attain the Hb levels of above 11 g/dL. The observation period established was 24 weeks, and the primary endpoint investigated was the percentage of patients who achieved the Hb levels of above 10 g/dL and the delta (Δ) Hb levels of 1 g/dL from baseline. Results: The Hb levels of renal anemia patients treated with C. E. R. A. were successfully corrected above 11 g/dL. The percentage of patients who attained Hb levels of above 10 g/ dL and the Δ Hb levels of above 1 g/dL from baseline was found to be 91.7%. It was shown from the present study, moreover, that the safety profiles of C. E. R. A. were similar to those of existing ESAs, erythropoiesis stimulating agents, and that the antibodies against C. E. R. A. were not detected in all the patients examined. Conclusions: This study has firstly disclosed that the administrations of C. E. R. A. i. v. at a dose level of 50 μg once every 2 weeks provided smooth as well as gradual increases of the Hb levels in patients with renal anemia on hemodialysis.

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