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Efficacy and safety of darbepoetin alfa for anemia in children with chronic kidney disease: a multicenter prospective study in Japan
Authors:Motoshi Hattori  Osamu Uemura  Hiroshi Hataya  Shuichi Ito  Masataka Hisano  Toshiyuki Ohta  Shuichiro Fujinaga  Tomoo Kise  Yoshimitsu Gotoh  Akira Matsunaga  Naoko Ito  Tadao Akizawa
Affiliation: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
Abstract:

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 ≤13.0 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 naïve 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.
Keywords:
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