Effect of hemoglobin (Hb) maintenance of subcutaneous (SC) or intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in chronic kidney disease (CKD) patients not on dialysis

Yukio Yuzawa, Osamu Hotta, Hiromichi Suzuki, Tetsuya Oishi, Takahiro Mochizuki, Mikio Wakasa, Susumu Uda, Yutaka Kanno, Kazuhiro Horikawa, Soshun Hara, Shizunori Ichida, Kunio Morozumi, Hideaki Shimizu, Mikito Tsuyuki, Hirofumi Tamai, Hiroaki Asada, Tomohiko Naruse, Daijo Inaguma, Satoshi Suzuki, Hirotake KasugaEiji Ishimura, Enyu Imai, Atsushi Yamauchi, Yasushi Saika, Yoshihiko Saito, Masafumi Taki, Hideki Kawanishi, Jun Minakuchi, Kenji Yuasa, Susumu Miyake, Kazuhito Takeda, Chikao Yasunaga, Seiya Okuda, Masahiko Nakamoto, Takao Saito, Kazuhiko Tsuruya, Hideki Hirakata, Kei Hon, Masami Bessho, Yoshiharu Tsubakihara, Masashi Suzuki

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: C. E. R. A. (Continuous Erythropoietin Receptor Activator) is an innovative erythropoiesis stimulating agent (ESA) with unique activity against erythropoietin receptor, and shows a significantly prolonged half-life after the administration. In the present study we evaluated the efficacy and safety profiles of subcutaneous (SC) or intravenous (IV) C. E. R. A. dosing once every 4 weeks (Q4W) in Japanese patients chronic kidney disease (CKD) not on dialysis previously treated with recombinant human erythropoietin (rHuEPO). Methods: CKD patients (n = 101) not on dialysis were assigned to 100 μg (n = 78) or 150 μg (n = 23) of C. E. R. A. by depending on previous rHuEPO doses of under 4500 IU/wk or over 4500 IU/wk, respectively. C. E. R. A. was administered Q4W via either SC (n = 70) or IV (n = 31) routes based on doctor's decision. After 8 weeks in switching period, the doses of C. E. R. A. Q4W were adjusted from 25 to 400 μg to maintain Hb levels of 11-13 g/dL (10-12 g/dL, in the patients with any histories or complications of cardiovascular diseases) as a maintenance period for the following 40 weeks. Primary endpoint was the percentage of patients whose mean Hb levels were within the 11-13 g/dL during 18-24 weeks. Results: The percentages of patients whose mean Hb levels maintain within each target Hb of 11-13 g/dL and 10-12 g/dL during 18-24 weeks were 79.2% and 100%, respectively. No significant differences in the maintenance rate were found between SC and IV route for 48 weeks. The mean (SD) slope of regression line of Hb levels were 0.116 (0.148) g/dL/week after switching from rHuEPO to C. E. R. A. administration. This parameter was also similar between both routes. Adverse event profiles were similar to those reported in rHuEPO and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. could safely switch from rHuEPO by dosing Q4W, successfully maintain target Hb levels of 11-13 g/dL by dose adjustment and is generally well tolerated in Japanese patients with CKD not on dialysis.

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

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Chronic Renal Insufficiency
Dialysis
Hemoglobins
Maintenance
Erythropoietin
Hematinics
Erythropoietin Receptors
continuous erythropoietin receptor activator
Half-Life
Cardiovascular Diseases
Safety
Antibodies

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Yuzawa, Yukio ; Hotta, Osamu ; Suzuki, Hiromichi ; Oishi, Tetsuya ; Mochizuki, Takahiro ; Wakasa, Mikio ; Uda, Susumu ; Kanno, Yutaka ; Horikawa, Kazuhiro ; Hara, Soshun ; Ichida, Shizunori ; Morozumi, Kunio ; Shimizu, Hideaki ; Tsuyuki, Mikito ; Tamai, Hirofumi ; Asada, Hiroaki ; Naruse, Tomohiko ; Inaguma, Daijo ; Suzuki, Satoshi ; Kasuga, Hirotake ; Ishimura, Eiji ; Imai, Enyu ; Yamauchi, Atsushi ; Saika, Yasushi ; Saito, Yoshihiko ; Taki, Masafumi ; Kawanishi, Hideki ; Minakuchi, Jun ; Yuasa, Kenji ; Miyake, Susumu ; Takeda, Kazuhito ; Yasunaga, Chikao ; Okuda, Seiya ; Nakamoto, Masahiko ; Saito, Takao ; Tsuruya, Kazuhiko ; Hirakata, Hideki ; Hon, Kei ; Bessho, Masami ; Tsubakihara, Yoshiharu ; Suzuki, Masashi. / Effect of hemoglobin (Hb) maintenance of subcutaneous (SC) or intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in chronic kidney disease (CKD) patients not on dialysis. In: Japanese Pharmacology and Therapeutics. 2011 ; Vol. 39, No. SUPPL. 1.
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title = "Effect of hemoglobin (Hb) maintenance of subcutaneous (SC) or intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in chronic kidney disease (CKD) patients not on dialysis",
abstract = "Background: C. E. R. A. (Continuous Erythropoietin Receptor Activator) is an innovative erythropoiesis stimulating agent (ESA) with unique activity against erythropoietin receptor, and shows a significantly prolonged half-life after the administration. In the present study we evaluated the efficacy and safety profiles of subcutaneous (SC) or intravenous (IV) C. E. R. A. dosing once every 4 weeks (Q4W) in Japanese patients chronic kidney disease (CKD) not on dialysis previously treated with recombinant human erythropoietin (rHuEPO). Methods: CKD patients (n = 101) not on dialysis were assigned to 100 μg (n = 78) or 150 μg (n = 23) of C. E. R. A. by depending on previous rHuEPO doses of under 4500 IU/wk or over 4500 IU/wk, respectively. C. E. R. A. was administered Q4W via either SC (n = 70) or IV (n = 31) routes based on doctor's decision. After 8 weeks in switching period, the doses of C. E. R. A. Q4W were adjusted from 25 to 400 μg to maintain Hb levels of 11-13 g/dL (10-12 g/dL, in the patients with any histories or complications of cardiovascular diseases) as a maintenance period for the following 40 weeks. Primary endpoint was the percentage of patients whose mean Hb levels were within the 11-13 g/dL during 18-24 weeks. Results: The percentages of patients whose mean Hb levels maintain within each target Hb of 11-13 g/dL and 10-12 g/dL during 18-24 weeks were 79.2{\%} and 100{\%}, respectively. No significant differences in the maintenance rate were found between SC and IV route for 48 weeks. The mean (SD) slope of regression line of Hb levels were 0.116 (0.148) g/dL/week after switching from rHuEPO to C. E. R. A. administration. This parameter was also similar between both routes. Adverse event profiles were similar to those reported in rHuEPO and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. could safely switch from rHuEPO by dosing Q4W, successfully maintain target Hb levels of 11-13 g/dL by dose adjustment and is generally well tolerated in Japanese patients with CKD not on dialysis.",
author = "Yukio Yuzawa and Osamu Hotta and Hiromichi Suzuki and Tetsuya Oishi and Takahiro Mochizuki and Mikio Wakasa and Susumu Uda and Yutaka Kanno and Kazuhiro Horikawa and Soshun Hara and Shizunori Ichida and Kunio Morozumi and Hideaki Shimizu and Mikito Tsuyuki and Hirofumi Tamai and Hiroaki Asada and Tomohiko Naruse and Daijo Inaguma and Satoshi Suzuki and Hirotake Kasuga and Eiji Ishimura and Enyu Imai and Atsushi Yamauchi and Yasushi Saika and Yoshihiko Saito and Masafumi Taki and Hideki Kawanishi and Jun Minakuchi and Kenji Yuasa and Susumu Miyake and Kazuhito Takeda and Chikao Yasunaga and Seiya Okuda and Masahiko Nakamoto and Takao Saito and Kazuhiko Tsuruya and Hideki Hirakata and Kei Hon and Masami Bessho and Yoshiharu Tsubakihara 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",
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Yuzawa, Y, Hotta, O, Suzuki, H, Oishi, T, Mochizuki, T, Wakasa, M, Uda, S, Kanno, Y, Horikawa, K, Hara, S, Ichida, S, Morozumi, K, Shimizu, H, Tsuyuki, M, Tamai, H, Asada, H, Naruse, T, Inaguma, D, Suzuki, S, Kasuga, H, Ishimura, E, Imai, E, Yamauchi, A, Saika, Y, Saito, Y, Taki, M, Kawanishi, H, Minakuchi, J, Yuasa, K, Miyake, S, Takeda, K, Yasunaga, C, Okuda, S, Nakamoto, M, Saito, T, Tsuruya, K, Hirakata, H, Hon, K, Bessho, M, Tsubakihara, Y & Suzuki, M 2011, 'Effect of hemoglobin (Hb) maintenance of subcutaneous (SC) or intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in chronic kidney disease (CKD) patients not on dialysis', Japanese Pharmacology and Therapeutics, vol. 39, no. SUPPL. 1.

Effect of hemoglobin (Hb) maintenance of subcutaneous (SC) or intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in chronic kidney disease (CKD) patients not on dialysis. / Yuzawa, Yukio; Hotta, Osamu; Suzuki, Hiromichi; Oishi, Tetsuya; Mochizuki, Takahiro; Wakasa, Mikio; Uda, Susumu; Kanno, Yutaka; Horikawa, Kazuhiro; Hara, Soshun; Ichida, Shizunori; Morozumi, Kunio; Shimizu, Hideaki; Tsuyuki, Mikito; Tamai, Hirofumi; Asada, Hiroaki; Naruse, Tomohiko; Inaguma, Daijo; Suzuki, Satoshi; Kasuga, Hirotake; Ishimura, Eiji; Imai, Enyu; Yamauchi, Atsushi; Saika, Yasushi; Saito, Yoshihiko; Taki, Masafumi; Kawanishi, Hideki; Minakuchi, Jun; Yuasa, Kenji; Miyake, Susumu; Takeda, Kazuhito; Yasunaga, Chikao; Okuda, Seiya; Nakamoto, Masahiko; Saito, Takao; Tsuruya, Kazuhiko; Hirakata, Hideki; Hon, Kei; Bessho, Masami; Tsubakihara, Yoshiharu; 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 hemoglobin (Hb) maintenance of subcutaneous (SC) or intravenous (IV) C. E. R. A. (Continuous Erythropoietin Receptor Activator) in chronic kidney disease (CKD) patients not on dialysis

AU - Yuzawa, Yukio

AU - Hotta, Osamu

AU - Suzuki, Hiromichi

AU - Oishi, Tetsuya

AU - Mochizuki, Takahiro

AU - Wakasa, Mikio

AU - Uda, Susumu

AU - Kanno, Yutaka

AU - Horikawa, Kazuhiro

AU - Hara, Soshun

AU - Ichida, Shizunori

AU - Morozumi, Kunio

AU - Shimizu, Hideaki

AU - Tsuyuki, Mikito

AU - Tamai, Hirofumi

AU - Asada, Hiroaki

AU - Naruse, Tomohiko

AU - Inaguma, Daijo

AU - Suzuki, Satoshi

AU - Kasuga, Hirotake

AU - Ishimura, Eiji

AU - Imai, Enyu

AU - Yamauchi, Atsushi

AU - Saika, Yasushi

AU - Saito, Yoshihiko

AU - Taki, Masafumi

AU - Kawanishi, Hideki

AU - Minakuchi, Jun

AU - Yuasa, Kenji

AU - Miyake, Susumu

AU - Takeda, Kazuhito

AU - Yasunaga, Chikao

AU - Okuda, Seiya

AU - Nakamoto, Masahiko

AU - Saito, Takao

AU - Tsuruya, Kazuhiko

AU - Hirakata, Hideki

AU - Hon, Kei

AU - Bessho, Masami

AU - Tsubakihara, Yoshiharu

AU - Suzuki, Masashi

PY - 2011/5/10

Y1 - 2011/5/10

N2 - Background: C. E. R. A. (Continuous Erythropoietin Receptor Activator) is an innovative erythropoiesis stimulating agent (ESA) with unique activity against erythropoietin receptor, and shows a significantly prolonged half-life after the administration. In the present study we evaluated the efficacy and safety profiles of subcutaneous (SC) or intravenous (IV) C. E. R. A. dosing once every 4 weeks (Q4W) in Japanese patients chronic kidney disease (CKD) not on dialysis previously treated with recombinant human erythropoietin (rHuEPO). Methods: CKD patients (n = 101) not on dialysis were assigned to 100 μg (n = 78) or 150 μg (n = 23) of C. E. R. A. by depending on previous rHuEPO doses of under 4500 IU/wk or over 4500 IU/wk, respectively. C. E. R. A. was administered Q4W via either SC (n = 70) or IV (n = 31) routes based on doctor's decision. After 8 weeks in switching period, the doses of C. E. R. A. Q4W were adjusted from 25 to 400 μg to maintain Hb levels of 11-13 g/dL (10-12 g/dL, in the patients with any histories or complications of cardiovascular diseases) as a maintenance period for the following 40 weeks. Primary endpoint was the percentage of patients whose mean Hb levels were within the 11-13 g/dL during 18-24 weeks. Results: The percentages of patients whose mean Hb levels maintain within each target Hb of 11-13 g/dL and 10-12 g/dL during 18-24 weeks were 79.2% and 100%, respectively. No significant differences in the maintenance rate were found between SC and IV route for 48 weeks. The mean (SD) slope of regression line of Hb levels were 0.116 (0.148) g/dL/week after switching from rHuEPO to C. E. R. A. administration. This parameter was also similar between both routes. Adverse event profiles were similar to those reported in rHuEPO and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. could safely switch from rHuEPO by dosing Q4W, successfully maintain target Hb levels of 11-13 g/dL by dose adjustment and is generally well tolerated in Japanese patients with CKD not on dialysis.

AB - Background: C. E. R. A. (Continuous Erythropoietin Receptor Activator) is an innovative erythropoiesis stimulating agent (ESA) with unique activity against erythropoietin receptor, and shows a significantly prolonged half-life after the administration. In the present study we evaluated the efficacy and safety profiles of subcutaneous (SC) or intravenous (IV) C. E. R. A. dosing once every 4 weeks (Q4W) in Japanese patients chronic kidney disease (CKD) not on dialysis previously treated with recombinant human erythropoietin (rHuEPO). Methods: CKD patients (n = 101) not on dialysis were assigned to 100 μg (n = 78) or 150 μg (n = 23) of C. E. R. A. by depending on previous rHuEPO doses of under 4500 IU/wk or over 4500 IU/wk, respectively. C. E. R. A. was administered Q4W via either SC (n = 70) or IV (n = 31) routes based on doctor's decision. After 8 weeks in switching period, the doses of C. E. R. A. Q4W were adjusted from 25 to 400 μg to maintain Hb levels of 11-13 g/dL (10-12 g/dL, in the patients with any histories or complications of cardiovascular diseases) as a maintenance period for the following 40 weeks. Primary endpoint was the percentage of patients whose mean Hb levels were within the 11-13 g/dL during 18-24 weeks. Results: The percentages of patients whose mean Hb levels maintain within each target Hb of 11-13 g/dL and 10-12 g/dL during 18-24 weeks were 79.2% and 100%, respectively. No significant differences in the maintenance rate were found between SC and IV route for 48 weeks. The mean (SD) slope of regression line of Hb levels were 0.116 (0.148) g/dL/week after switching from rHuEPO to C. E. R. A. administration. This parameter was also similar between both routes. Adverse event profiles were similar to those reported in rHuEPO and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. could safely switch from rHuEPO by dosing Q4W, successfully maintain target Hb levels of 11-13 g/dL by dose adjustment and is generally well tolerated in Japanese patients with CKD not on dialysis.

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VL - 39

JO - Japanese Pharmacology and Therapeutics

JF - Japanese Pharmacology and Therapeutics

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