Darbepoetin, effective treatment of anaemia in paediatric patients with chronic renal failure

André, Jean-Luc; Deschênes, Georges; Boudailliez, B; Broux, Françoise; Fischbach, Michel; Gagnadoux, Marie‐France; Horen, Benjamin; Lahoche-Manucci, A.; Macher, Marie‐Alice; Roussel, Bernard; Tsimaratos, Michel; Loirat, Chantal

doi:10.1007/s00467-006-0402-1

Cited by 16 publications

(6 citation statements)

References 29 publications

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“…Together with the relatively low proportion of patients requiring RBC transfusion (15 %), these findings suggest that DA was effective in managing anemia in these patients. This result is in line with that of a previous study of DA in 39 children aged 11–18 years in which most patients achieved stable Hb concentrations after 6 months, whether they had switched to DA from rHuEpo or were ESA-naive [ 19 ], and with the results of two Japanese studies in children aged 1–18 years with CKD who switched from rHuEpo or were ESA-naive [ 15 , 16 ].…”

Section: Discussionsupporting

confidence: 91%

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

et al. 2015

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BackgroundLimited prospective data are available on the long-term safety of darbepoetin alfa (DA) for treating anemia in children with chronic kidney disease (CKD).MethodsIn 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.ResultsA 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.ConclusionsNo 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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Section: Discussionsupporting

confidence: 91%

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

et al. 2015

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“…15 In the present study, DA was given as 0.5 mg/kg weekly doses (mean initial dose, 0.48 Ϯ 0.1 mg/kg/week) and we observed that Hb increased significantly in the DA-treated patients during the study, and we conclude that DA is efficient in the treatment of renal anemia. Moreover, we compared the efficacy of DA to rHuEPO, and found no difference between them.…”

Section: Discussionmentioning

confidence: 64%

“…8,17 The most commonly reported side-effects related to use of DA are hypertension, infection, hypotension, myalgia, headache, diarrhea and injection pain. 12,14,15 We observed a short-term, high SBP in only one patient in the DA group. We did not initiate any medication because the patient's BP had normalized during follow-up.…”

Section: Discussionmentioning

confidence: 71%

Comparison of recombinant human erythropoietin and darbepoetin alpha in children

Can

Emre

Bilge

et al. 2013

Pediatrics International

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“…Results (dosage, frequency of administration, side effects, etc.) of treatment with DA in the pediatric field have been reported from Europe and the US (185–188). These results have revealed that initiation of DA decreased the frequency of administration, suggesting that this drug would confer a great benefit particularly on children in whom consideration to pain, compliance, burden of the family, and other factors is required.…”

mentioning

confidence: 96%

2008 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

Tsubakihara

Nishi

Akiba³

et al. 2010

Ther Apher Dial

222

276

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The Japanese Society for Dialysis Therapy (JSDT) guideline committee, chaired by Dr Y. Tsubakihara, presents the Japanese guidelines entitled "Guidelines for Renal Anemia in Chronic Kidney Disease." These guidelines replace the "2004 JSDT Guidelines for Renal Anemia in Chronic Hemodialysis Patients," and contain new, additional guidelines for peritoneal dialysis (PD), non-dialysis (ND), and pediatric chronic kidney disease (CKD) patients. Chapter 1 presents reference values for diagnosing anemia that are based on the most recent epidemiological data from the general Japanese population. In both men and women, hemoglobin (Hb) levels decrease along with an increase in age and the level for diagnosing anemia has been set at <13.5 g/dL in males and <11.5 g/dL in females. However, the guidelines explicitly state that the target Hb level in erythropoiesis stimulating agent (ESA) therapy is different to the anemia reference level. In addition, in defining renal anemia, the guidelines emphasize that the reduced production of erythropoietin (EPO) that is associated with renal disorders is the primary cause of renal anemia, and that renal anemia refers to a condition in which there is no increased production of EPO and serum EPO levels remain within the reference range for healthy individuals without anemia, irrespective of the glomerular filtration rate (GFR). In other words, renal anemia is clearly identified as an "endocrine disease." It is believed that defining renal anemia in this way will be extremely beneficial for ND patients exhibiting renal anemia despite having a high GFR. We have also emphasized that renal anemia may be treated not only with ESA therapy but also with appropriate iron supplementation and the improvement of anemia associated with chronic disease, which is associated with inflammation, and inadequate dialysis, another major cause of renal anemia. In Chapter 2, which discusses the target Hb levels in ESA therapy, the guidelines establish different target levels for hemodialysis (HD) patients than for PD and ND patients, for two reasons: (i) In Japanese HD patients, Hb levels following hemodialysis rise considerably above their previous levels because of ultrafiltration-induced hemoconcentration; and (ii) as noted in the 2004 guidelines, although 10 to 11 g/dL was optimal for long-term prognosis if the Hb level prior to the hemodialysis session in an HD patient had been established at the target level, it has been reported that, based on data accumulated on Japanese PD and ND patients, in patients without serious cardiovascular disease, higher levels have a cardiac or renal function protective effect, without any safety issues. Accordingly, the guidelines establish a target Hb level in PD and ND patients of 11 g/dL or more, and recommend 13 g/dL as the criterion for dose reduction/withdrawal. However, with the results of, for example, the CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) study in mind, the guidelines establish an upper limit of 12 g/dL for patients with serious c...

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Darbepoetin, effective treatment of anaemia in paediatric patients with chronic renal failure

Cited by 16 publications

References 29 publications

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

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

Comparison of recombinant human erythropoietin and darbepoetin alpha in children

2008 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

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