Abstract
BackgroundRenal 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.MethodsThis 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.ResultsThe 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.ConclusionBy 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.
Highlights
Chronic kidney disease (CKD) is a common health disorder worldwide, and its age-adjusted mortality rate has grown annually [1]
The subjects consist of chronic kidney disease (CKD) patients with estimated glomerular filtration rate below 60 mL/min/ 1.73 m2 who present renal anemia
Renal function and cardiovascular disease (CVD) events will be observed for 96 weeks after the initiation of darbepoetin alfa administration
Summary
Chronic kidney disease (CKD) is a common health disorder worldwide, and its age-adjusted mortality rate has grown annually [1]. Renal anemia is treated using recombinant human erythropoietin (rHuEPO) or other erythropoiesis-stimulating agent (ESA). 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. Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan 4 Department of Kidney Disease and Hypertension, Osaka General Medical Centre, Sumiyoshi, Osaka, Japan 5 Division of Clinical Pharmacology and Therapeutics, Tohoku University Graduate School of Pharmaceutical Sciences and Faculty of Pharmaceutical Sciences, Sendai, Miyagi, Japan 6 Department of Nephrology and Rheumatology, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa, Japan 7 Department of Nephrology, Hiroshima University Hospital, Hiroshima, Hiroshima, Japan 8 Translational Research Informatics Center, Foundation Biomedical Research and Innovation, Kobe, Hyogo, Japan 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
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