Efficacy and safety of darbepoetin alfa for anemia in children with chronic kidney disease: a multicenter prospective study in Japan

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• 作者：Motoshi Hattori (1)
  Osamu Uemura (2)
  Hiroshi Hataya (3)
  Shuichi Ito (4)
  Masataka Hisano (5)
  Toshiyuki Ohta (6)
  Shuichiro Fujinaga (7)
  Tomoo Kise (8)
  Yoshimitsu Gotoh (9)
  Akira Matsunaga (10)
  Naoko Ito (11)
  Tadao Akizawa (12)
  
• 关键词：Anemia ; Chronic kidney disease ; Darbepoetin alfa ; Children
• 刊名：Clinical and Experimental Nephrology
• 出版年：2014
• 出版时间：August 2014
• 年：2014
• 卷：18
• 期：4
• 页码：634-641
• 全文大小：854 KB
• 参考文献：1. Koshy SM, Geary DF. Anemia in children with chronic kidney disease. Pediatr Nephrol. 2008;23:209-9. CrossRef
  2. Atkinson MA, Furth SL. Anemia in children with chronic kidney disease. Nat Rev Nephrol. 2011;7:635-1. CrossRef
  3. Gary L, Kale AS, Warady BA, Jabs K, Bunchman TE, Heatherington A, et al. Pharmacokinetics of darbepoetin alfa in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2002;17:933-. CrossRef
  4. Jadoul M, Vanrenterghem Y, Foret M, Walker R, Gray SJ. Darbepoetin alfa administered once monthly maintains hemoglobin levels in stable dialysis patients. Nephrol Dial Transplant. 2004;19:898-03. CrossRef
  5. Brunkhorst R, Bommer J, Braum J, Hagg-Weber M, Gill C, Wagner J, et al. Darbepoetin alfa effectively maintains hemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Nephrol Dial Transplant. 2004;19:1224-0. CrossRef
  6. Hiramatsu M, Kubota M, Iwasaki M, Akizawa T, Kosikawa S, the KRN321 A09 Study Group. Darbepoetin alfa (KRN321) administered intravenously once monthly maintains hemoglobin levels in peritoneal dialysis patients. Ther Apher Dial. 2008;12:19-7. CrossRef
  7. Kubota M, Hiramatsu M, Yamakawa M, Fukuhara S, Morita S, Iwasaki M, et al. Darbepoetin alfa (KRN321) is safe and effective when administered subcutaneously once every 2 or 4?weeks to patients on peritoneal dialysis in Japan. Clin Exp Nephrol. 2011;15:884-2. CrossRef
  8. De Palo T, Giordano M, Palumbo F, Bellantuono R, Messina G, Colella V, et al. Clinical experience with darbepoetin alfa (NESP) in children undergoing hemodialysis. Pediatr Nephrol. 2004;19:337-0. CrossRef
  9. Geary DF, Keating LE, Vigneux A, Stephens D, Hebert D, Harvey EA. Darbepoetin alfa (Aranesp? in children with chronic renal failure. Kidney Int. 2005;68:1759-5. CrossRef
  10. Warady BA, Arar MY, Lerner G, Nakanishi AM, Stehman-Breen C. Darbepoetin alfa for the treatment of anemia in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2006;21:1144-2. CrossRef
  11. Andre JL, Deschenes G, Boudailliez B, Broux F, Fischbach M, Gagnadoux M-F, et al. Darbepoetin, effective treatment of anaemia in paediatric patients with chronic renal failure. Pediatr Nephrol. 2007;22:708-4. CrossRef
  12. Hattori M, Matsunaga A, Akioka Y, Fujinaga S, Nagai T, Uemura O, et al. Darbepoetin alfa for the treatment of anemia in children undergoing peritoneal dialysis: a multicenter prospective study in Japan. Clin Exp Nephrol. 2013;17:582-.
  13. 2008 Japanese Society for Dialysis Therapy guideline for renal anemia in chronic kidney disease. J Jpn Soc Dial Ther. 2008;41:661-16.
  14. Akizawa T, Gejyo F, Suzuki M, Akiba T, Iino Y, Saito A, et al. Efficacy and safety of subcutaneous or intravenous administration of KRN321 (darbepoetin alfa) in patients with chronic kidney disease not on dialysis or those on peritoneal dialysis. Kidney Dial. 2011;71:887-8 (in Japanese).
  15. Akizawa T, Ishida H, Matsui N, Iizuka T, Asano Y, Homma S, et al. Dose-evaluation study of intravenous KRN321 (darbepoetin alfa) in EPO-na?ve hemodialysis patients in Japan. Kidney Dial. 2010;68:423-5 (in Japanese).
  16. Nishi S, Gejyo F, Shigematsu T, Iino Y, Hosoya T, Shoji T et al. The validity of the transition from rHuEPO to KRN321 in chronic kidney disease (CKD) patients not on dialysis. Kidney Dial. 2010;68:284-4 (in Japanese).
  17. Schwartz GJ, Brion LP, Spitzer A. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clin North Am. 1987;34:571-0.
  18. An overview of dialysis treatment in Japan (as of Dec. 31, 2011). J Jpn Soc Dial Ther. 2013;46:1-6 (in Japanese).
  19. Ishikura K, Uemura O, Ito S, Wada N, Hattori M, Ohashi Y et al. Pre-dialysis chronic kidney disease in children: results of a nationwide survey in Japan. Nephrol Dial Transplant. 2013 (in press).
  20. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/Step4/E11_Guideline.pdf. Accessed 14 June 2013.
  
• 作者单位：Motoshi Hattori (1)
  Osamu Uemura (2)
  Hiroshi Hataya (3)
  Shuichi Ito (4)
  Masataka Hisano (5)
  Toshiyuki Ohta (6)
  Shuichiro Fujinaga (7)
  Tomoo Kise (8)
  Yoshimitsu Gotoh (9)
  Akira Matsunaga (10)
  Naoko Ito (11)
  Tadao Akizawa (12)
  
  1. Department of Pediatric Nephrology, Tokyo Women’s Medical University, School of Medicine, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
  2. Department of Pediatric Nephrology, Aichi Children’s Health and Medical Center, Aichi, Japan
  3. Department of Nephrology, Tokyo Metropolitan Children’s Medical Center, Tokyo, Japan
  4. Division of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan
  5. Division of Nephrology, Chiba Children’s Hospital, Chiba, Japan
  6. Department of Pediatric Nephrology, Hiroshima Prefectural Hospital, Hiroshima, Japan
  7. Division of Nephrology, Saitama Children’s Medical Center, Saitama, Japan
  8. Okinawa Prefectural Nanbu Medical Center and Children’s Medical Center, Okinawa, Japan
  9. Department of Pediatric Nephrology, Nagoya Daini Red Cross Hospital, Aichi, Japan
  10. Department of Pediatrics, Yamagata University School of Medicine, Yamagata, Japan
  11. Department of Pediatrics, Kyushu University School of Medicine, Fukuoka, Japan
  12. Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan
  
• ISSN：1437-7799

文摘

Background We evaluated the safety and efficacy of darbepoetin alfa (DA), an attractive alternative to recombinant human erythropoietin (rHuEPO) in managing renal anemia, in Japanese children with chronic kidney disease (CKD) on peritoneal dialysis (PD) and hemodialysis (HD), and not on dialysis (ND). Methods A total of 31 pediatric CKD patients (13 PD, 2 HD, and 16 ND) were enrolled. DA was administered bi-weekly intravenously (IV) or subcutaneously (SC) for PD or ND patients, and weekly IV for HD patients for 24?weeks. The target Hb was defined as 11.0 to ?3.0?g/dl. In patients receiving rHuEPO, the initial DA dose was calculated at 1?μg DA for 200?IU rHuEPO. The initial DA dose for na?ve patients was determined by body weight, and intended not to exceed 0.5?μg/kg per administration. For some PD or ND patients, the dosing frequency was subsequently changed to once every 4?weeks. Results Mean Hb values increased from 10.5?±?1.1 to 11.1?±?1.1?g/dl after 4 weeks of DA treatment. The target Hb was achieved in all patients, 64.5?% of whom maintained the value at completion of the study. Hb responses were similar between IV and SC. The dosing frequency was extended to once every 4?weeks in 37.9?% of PD or ND patients. Eighty-seven adverse events were noted in 27 (87.1?%) of 31 patients, none of which were associated with DA. Conclusion These results suggest that IV or SC administration of DA is an effective and safe treatment for renal anemia in Japanese children with CKD.