Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study

. 2016 Mar ; 31 (3) : 443-53. [epub] 20151019

Jazyk angličtina Země Německo Médium print-electronic

Typ dokumentu klinické zkoušky, fáze IV, časopisecké články, multicentrická studie, pozorovací studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid26482252
Odkazy

PubMed 26482252
PubMed Central PMC4756039
DOI 10.1007/s00467-015-3225-0
PII: 10.1007/s00467-015-3225-0
Knihovny.cz E-zdroje

BACKGROUND: Limited prospective data are available on the long-term safety of darbepoetin alfa (DA) for treating anemia in children with chronic kidney disease (CKD). METHODS: In this prospective, phase IV, observational registry study, children ≤16 years of age with CKD anemia and receiving DA were observed for ≤2 years. Adverse events (AEs), DA dosing, hemoglobin (Hb) concentrations, and transfusions were recorded. RESULTS: A total of 319 patients were included in the analysis (mean age, 9.1 years), 158 (49.5%) of whom were on dialysis at study entry. Of 434 serious AEs reported in 162 children, the most common were peritonitis (10.0%), gastroenteritis (6.0%), and hypertension (4.1%). Six patients (1.9%) died (unrelated to DA). Four patients (1.3%) experienced six serious adverse drug reactions. The geometric mean DA dose range was 1.4-2.0 μg/kg/month. Mean baseline Hb concentration was 11.1 g/dl; mean values for children receiving and not receiving dialysis at baseline ranged between 10.9 and 11.5 g/dl and 11.2-11.7 g/dl, respectively. Overall, 48 patients (15.0%) received ≥1 transfusion. CONCLUSIONS: No new safety signals for DA were identified in children receiving DA for CKD anemia for ≤2 years. Based on Hb concentrations and transfusion requirements, DA was effective at managing anemia in these patients.

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Chesnaye N, Bonthuis M, Schaefer F, ESPN/ERA-EDTA registry Demographics of paeditric renal replacement therapy in Europe: a report of the ESPN/ERA = EDTA registry. Pediatr Nephrol. 2014;29:2403–24102. doi: 10.1007/s00467-014-2884-6. PubMed DOI

WHO Regional Office for Europe (2012) European Mortality Data Base http://www.euro.who.int/en/data-and-evidence/databases

McDonald SP, Craig JC. Long-term survival of children with end-stage renal disease. N Engl J Med. 2004;350:2654–2662. doi: 10.1056/NEJMoa031643. PubMed DOI

Fivush BA, Jabs K, Neu AM, Sullivan EK, Feld L, Kohaut E, Fine R. Chronic renal insufficiency in children and adolescents: the 1996 annual report of NAPRTCS. North American Pediatric Renal Transplant Cooperative Study. Pediatr Nephrol. 1998;12:328–337. doi: 10.1007/s004670050462. PubMed DOI

Wong H, Mylrea K, Feber J, Drukker A, Filler G. Prevalence of complications in children with chronic kidney disease according to KDOQI. Kidney Int. 2006;70:585–590. doi: 10.1038/sj.ki.5001608. PubMed DOI

Kramer AM, van Stralen KJ, Jager KJ, Schaefer F, Verrina E, Seeman T, Lewis MA, Boehm M, Simonetti GD, Novljan G, Groothoff JW. Demographics of blood pressure and hypertension in children on renal replacement therapy in Europe. Kidney Int. 2011;80:1092–1098. doi: 10.1038/ki.2011.232. PubMed DOI

Van Stralen KJ, Krischock L, Schaefer F, ESPN/ERA-EDTA registry Prevalence and predictors of the sub-target Hb level in children on dialysis. Nephrol Dial Transplant. 2012;27:3950–3957. doi: 10.1093/ndt/gfs178. PubMed DOI

Staples AO, Wong CS, Smith JM, Gipson DS, Filler G, Warady BA, Martz K, Greenbaum LA. Anemia and risk of hospitalization in pediatric chronic kidney disease. Clin J Am Soc Nephrol. 2009;4:48–56. doi: 10.2215/CJN.05301107. PubMed DOI PMC

Chavers BM, Roberts TL, Herzog CA, Collins AJ, St Peter WL. Prevalence of anemia in erythropoietin-treated pediatric as compared to adult chronic dialysis patients. Kidney Int. 2004;65(1):266–273. doi: 10.1111/j.1523-1755.2004.00357.x. PubMed DOI

Aranesp. Product information. Annex I: Summary of product characteristics. Last updated 6 November 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf

The National Clinical Guideline Centre. Anaemia management in Chronic Kidney Disease. Commissioned by the National Institute for Health and Clinical Excellence, 2011. http://www.nice.org.uk/nicemedia/live/13329/52851/52851.pdf

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;21:1144–1152. doi: 10.1007/s00467-006-0071-0. PubMed DOI

Geary DF, Keating LE, Vigneux A, Stephens D, Hébert D, Harvey EA. Darbepoetin alfa (Aranesp) in children with chronic renal failure. Kidney Int. 2005;68:1759–1765. doi: 10.1111/j.1523-1755.2005.00592.x. PubMed DOI

Durkan AM, Keating LE, Vigneux A, Geary DF. The use of darbepoetin in infants with chronic renal impairment. Pediatr Nephrol. 2006;21:694–697. doi: 10.1007/s00467-006-0067-9. PubMed DOI

Hattori M, Matsunaga A, Akioka Y, Fujinaga S, Nagai T, Uemura O, Nakakura H, Ashida A, Kamei K, Ito S, Yamada T, Goto Y, Ohta T, Hisano M, Komatsu Y, Itami N. Darbepoetin alfa for the treatment of anemia in children undergoing peritoneal dialysis: a multicenter prospective study in Japan. Clin Exp Nephrol. 2013;17:582–588. doi: 10.1007/s10157-012-0714-3. PubMed DOI

Hattori M, Uemura O, Hataya H, Ito S, Hisano M, Ohta T, Fujinaga S, Kise T, Gotoh Y, Matsunaga A, Ito N, Akizawa T, The KRN321 Pediatric Study Group Efficacy and safety of darbepoetin alfa for anemia in children with chronic kidney disease: a multicenter prospective study in Japan. Clin Exp Nephrol. 2014;18:634–641. doi: 10.1007/s10157-013-0859-8. PubMed DOI

World Health Organization (2011) Vitamin and mineral nutrition information system (VMNIS). Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity. Available at: http://www.who.int/vmnis/indicators/haemoglobin.pdf

Marks PW, Glader B (2009) Approach to anemia in the adult and child. In: Hoffman F, Benz EJ, Shattil SJ, eds. Hematology: Basic Principles and Practice. 5th ed. Churchill Livingstone, Philadelphia, PA: Chapter 34: 439–446

André JL, Deschênes G, Boudailliez B, Broux F, Fischbach M, Gagnadoux MF, Horen B, Lahoche-Manucci A, Macher MA, Roussel B, Tsimaratos M, Loirat C. Darbepoetin, effective treatment of anaemia in paediatric patients with chronic renal failure. Pediatr Nephrol. 2007;22:708–714. doi: 10.1007/s00467-006-0402-1. PubMed DOI PMC

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