Rationale and design of oBservational clinical Research In chronic kidney disease patients with renal anemia: renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis-stimulating agents, darbepoetiN alfa (BRIGHTEN Trial)

Hideki Kato, Masaomi Nangaku, Hideki Hirakata, Takashi Wada, Terumasa Hayashi, Hiroshi Sato, Yasushi Yamazaki, Takao Masaki, Tatsuo Kagimura, Hiroyasu Yamamoto, Hiroki Hase, Masahiro Kamouchi, Enyu Imai, Kyoichi Mizuno, Manabu Iwasaki, Tadao Akizawa, Yoshiharu Tsubakihara, Shoichi Maruyama, Ichiei Narita

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Renal anemia is an important complication in non-dialysis chronic kidney disease (CKD) patients as well as in dialysis patients. Although recombinant human erythropoietin has dramatically improved prognosis and quality of life in these patients, there have been issues among non-dialysis CKD patients who exhibit hyporesponsiveness to erythropoiesis-stimulating agent (ESA). The causes and definition of ESA hyporesponsiveness, as well as the incidence of renal and cardiovascular disease (CVD) events in such patients, are yet to be clarified. Methods: This ongoing trial is a multicenter, prospective, observational study of non-dialysis CKD patients with renal anemia. The primary objective is to survey the current realities of the therapy with ESA in Japan and evaluate the correlation between hyporesponsiveness to darbepoetin alfa and CKD progression. The secondary objective is to investigate relationship between ESA hyporesponsiveness and CVD events based on the clinical situation in Japan, and to explore an ESA response index. Results: The subjects consist of CKD patients with estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 who present renal anemia. The target number of registered cases is 2000 patients, based on estimates of incidences of renal and CVD events from past studies. Renal function and CVD events will be observed for 96 weeks after the initiation of darbepoetin alfa administration. Definitions of ESA hyporesponsiveness will also be investigated. Conclusion: By clarifying markers and factors involved in ESA hyporesponsiveness and their relationships with renal and CVD events, this ongoing study aims to improve evidence-based therapies for renal anemia in non-dialysis CKD patients.

Original languageEnglish
Pages (from-to)78-84
Number of pages7
JournalClinical and Experimental Nephrology
Volume22
Issue number1
DOIs
Publication statusPublished - Feb 1 2018

Fingerprint

Hematinics
Chronic Renal Insufficiency
Anemia
Kidney
Research
Cardiovascular Diseases
Reality Therapy
Japan
Darbepoetin alfa
Incidence
Erythropoietin
Glomerular Filtration Rate
Observational Studies
Disease Progression
Dialysis
Quality of Life
Prospective Studies

All Science Journal Classification (ASJC) codes

  • Physiology
  • Nephrology
  • Physiology (medical)

Cite this

Rationale and design of oBservational clinical Research In chronic kidney disease patients with renal anemia : renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis-stimulating agents, darbepoetiN alfa (BRIGHTEN Trial). / Kato, Hideki; Nangaku, Masaomi; Hirakata, Hideki; Wada, Takashi; Hayashi, Terumasa; Sato, Hiroshi; Yamazaki, Yasushi; Masaki, Takao; Kagimura, Tatsuo; Yamamoto, Hiroyasu; Hase, Hiroki; Kamouchi, Masahiro; Imai, Enyu; Mizuno, Kyoichi; Iwasaki, Manabu; Akizawa, Tadao; Tsubakihara, Yoshiharu; Maruyama, Shoichi; Narita, Ichiei.

In: Clinical and Experimental Nephrology, Vol. 22, No. 1, 01.02.2018, p. 78-84.

Research output: Contribution to journalArticle

Kato, H, Nangaku, M, Hirakata, H, Wada, T, Hayashi, T, Sato, H, Yamazaki, Y, Masaki, T, Kagimura, T, Yamamoto, H, Hase, H, Kamouchi, M, Imai, E, Mizuno, K, Iwasaki, M, Akizawa, T, Tsubakihara, Y, Maruyama, S & Narita, I 2018, 'Rationale and design of oBservational clinical Research In chronic kidney disease patients with renal anemia: renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis-stimulating agents, darbepoetiN alfa (BRIGHTEN Trial)', Clinical and Experimental Nephrology, vol. 22, no. 1, pp. 78-84. https://doi.org/10.1007/s10157-017-1427-4
Kato, Hideki ; Nangaku, Masaomi ; Hirakata, Hideki ; Wada, Takashi ; Hayashi, Terumasa ; Sato, Hiroshi ; Yamazaki, Yasushi ; Masaki, Takao ; Kagimura, Tatsuo ; Yamamoto, Hiroyasu ; Hase, Hiroki ; Kamouchi, Masahiro ; Imai, Enyu ; Mizuno, Kyoichi ; Iwasaki, Manabu ; Akizawa, Tadao ; Tsubakihara, Yoshiharu ; Maruyama, Shoichi ; Narita, Ichiei. / Rationale and design of oBservational clinical Research In chronic kidney disease patients with renal anemia : renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis-stimulating agents, darbepoetiN alfa (BRIGHTEN Trial). In: Clinical and Experimental Nephrology. 2018 ; Vol. 22, No. 1. pp. 78-84.
@article{ecdfae0126e34b58979c013ddda79ad0,
title = "Rationale and design of oBservational clinical Research In chronic kidney disease patients with renal anemia: renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis-stimulating agents, darbepoetiN alfa (BRIGHTEN Trial)",
abstract = "Background: Renal anemia is an important complication in non-dialysis chronic kidney disease (CKD) patients as well as in dialysis patients. Although recombinant human erythropoietin has dramatically improved prognosis and quality of life in these patients, there have been issues among non-dialysis CKD patients who exhibit hyporesponsiveness to erythropoiesis-stimulating agent (ESA). The causes and definition of ESA hyporesponsiveness, as well as the incidence of renal and cardiovascular disease (CVD) events in such patients, are yet to be clarified. Methods: This ongoing trial is a multicenter, prospective, observational study of non-dialysis CKD patients with renal anemia. The primary objective is to survey the current realities of the therapy with ESA in Japan and evaluate the correlation between hyporesponsiveness to darbepoetin alfa and CKD progression. The secondary objective is to investigate relationship between ESA hyporesponsiveness and CVD events based on the clinical situation in Japan, and to explore an ESA response index. Results: The subjects consist of CKD patients with estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 who present renal anemia. The target number of registered cases is 2000 patients, based on estimates of incidences of renal and CVD events from past studies. Renal function and CVD events will be observed for 96 weeks after the initiation of darbepoetin alfa administration. Definitions of ESA hyporesponsiveness will also be investigated. Conclusion: By clarifying markers and factors involved in ESA hyporesponsiveness and their relationships with renal and CVD events, this ongoing study aims to improve evidence-based therapies for renal anemia in non-dialysis CKD patients.",
author = "Hideki Kato and Masaomi Nangaku and Hideki Hirakata and Takashi Wada and Terumasa Hayashi and Hiroshi Sato and Yasushi Yamazaki and Takao Masaki and Tatsuo Kagimura and Hiroyasu Yamamoto and Hiroki Hase and Masahiro Kamouchi and Enyu Imai and Kyoichi Mizuno and Manabu Iwasaki and Tadao Akizawa and Yoshiharu Tsubakihara and Shoichi Maruyama and Ichiei Narita",
year = "2018",
month = "2",
day = "1",
doi = "10.1007/s10157-017-1427-4",
language = "English",
volume = "22",
pages = "78--84",
journal = "Clinical and Experimental Nephrology",
issn = "1342-1751",
publisher = "Springer Japan",
number = "1",

}

TY - JOUR

T1 - Rationale and design of oBservational clinical Research In chronic kidney disease patients with renal anemia

T2 - renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis-stimulating agents, darbepoetiN alfa (BRIGHTEN Trial)

AU - Kato, Hideki

AU - Nangaku, Masaomi

AU - Hirakata, Hideki

AU - Wada, Takashi

AU - Hayashi, Terumasa

AU - Sato, Hiroshi

AU - Yamazaki, Yasushi

AU - Masaki, Takao

AU - Kagimura, Tatsuo

AU - Yamamoto, Hiroyasu

AU - Hase, Hiroki

AU - Kamouchi, Masahiro

AU - Imai, Enyu

AU - Mizuno, Kyoichi

AU - Iwasaki, Manabu

AU - Akizawa, Tadao

AU - Tsubakihara, Yoshiharu

AU - Maruyama, Shoichi

AU - Narita, Ichiei

PY - 2018/2/1

Y1 - 2018/2/1

N2 - Background: Renal anemia is an important complication in non-dialysis chronic kidney disease (CKD) patients as well as in dialysis patients. Although recombinant human erythropoietin has dramatically improved prognosis and quality of life in these patients, there have been issues among non-dialysis CKD patients who exhibit hyporesponsiveness to erythropoiesis-stimulating agent (ESA). The causes and definition of ESA hyporesponsiveness, as well as the incidence of renal and cardiovascular disease (CVD) events in such patients, are yet to be clarified. Methods: This ongoing trial is a multicenter, prospective, observational study of non-dialysis CKD patients with renal anemia. The primary objective is to survey the current realities of the therapy with ESA in Japan and evaluate the correlation between hyporesponsiveness to darbepoetin alfa and CKD progression. The secondary objective is to investigate relationship between ESA hyporesponsiveness and CVD events based on the clinical situation in Japan, and to explore an ESA response index. Results: The subjects consist of CKD patients with estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 who present renal anemia. The target number of registered cases is 2000 patients, based on estimates of incidences of renal and CVD events from past studies. Renal function and CVD events will be observed for 96 weeks after the initiation of darbepoetin alfa administration. Definitions of ESA hyporesponsiveness will also be investigated. Conclusion: By clarifying markers and factors involved in ESA hyporesponsiveness and their relationships with renal and CVD events, this ongoing study aims to improve evidence-based therapies for renal anemia in non-dialysis CKD patients.

AB - Background: Renal anemia is an important complication in non-dialysis chronic kidney disease (CKD) patients as well as in dialysis patients. Although recombinant human erythropoietin has dramatically improved prognosis and quality of life in these patients, there have been issues among non-dialysis CKD patients who exhibit hyporesponsiveness to erythropoiesis-stimulating agent (ESA). The causes and definition of ESA hyporesponsiveness, as well as the incidence of renal and cardiovascular disease (CVD) events in such patients, are yet to be clarified. Methods: This ongoing trial is a multicenter, prospective, observational study of non-dialysis CKD patients with renal anemia. The primary objective is to survey the current realities of the therapy with ESA in Japan and evaluate the correlation between hyporesponsiveness to darbepoetin alfa and CKD progression. The secondary objective is to investigate relationship between ESA hyporesponsiveness and CVD events based on the clinical situation in Japan, and to explore an ESA response index. Results: The subjects consist of CKD patients with estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 who present renal anemia. The target number of registered cases is 2000 patients, based on estimates of incidences of renal and CVD events from past studies. Renal function and CVD events will be observed for 96 weeks after the initiation of darbepoetin alfa administration. Definitions of ESA hyporesponsiveness will also be investigated. Conclusion: By clarifying markers and factors involved in ESA hyporesponsiveness and their relationships with renal and CVD events, this ongoing study aims to improve evidence-based therapies for renal anemia in non-dialysis CKD patients.

UR - http://www.scopus.com/inward/record.url?scp=85025075562&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85025075562&partnerID=8YFLogxK

U2 - 10.1007/s10157-017-1427-4

DO - 10.1007/s10157-017-1427-4

M3 - Article

C2 - 28660446

AN - SCOPUS:85025075562

VL - 22

SP - 78

EP - 84

JO - Clinical and Experimental Nephrology

JF - Clinical and Experimental Nephrology

SN - 1342-1751

IS - 1

ER -