Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients

Vanrenterghem, Yves; Bárány, Peter; Mann, Johannes F.E.; Kerr, Peter G.; Wilson, Janet M; Baker, Nigel; Gray, Stephen J.

doi:10.1046/j.1523-1755.2002.00657.x

Cited by 160 publications

(141 citation statements)

References 19 publications

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“…Nevertheless, although darbepoetin-alpha-treated animals had Hb levels approximately 3 g/dl lower than transfused mice on the day of CRT, equivalent effects on the nadir and duration of anaemia were noted for each treatment. This result was in keeping with clinical data demonstrating the advantage of rHuEPO over transfusion and further supported by recent clinical studies with darbepoetin alpha (Nissenson et al, 2002;Vanrenterghem et al, 2002).…”

Section: Discussionsupporting

confidence: 87%

Kinetics of haematopoietic recovery after dose‐intensive chemo/radiotherapy in mice: optimized erythroid support with darbepoetin alpha

et al. 2003

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Summary. Despite its frequency and impact on clinical outcomes, anaemia in cancer patients remains poorly understood and suboptimally treated. The definition of optimum treatment schedules with erythropoietic agents requires a suitable model of chemotherapy-induced progressive anaemia. This study investigated novel strategies such as once-per-chemotherapy-cycle dosing, synchronization between erythroid supportive care and chemotherapy, and definition of the optimum timing of erythroid support. A murine model of carboplatin chemotherapy/radiotherapy (CRT)-induced anaemia was used, which caused progressive anaemia across multiple cycles. Weekly administration of recombinant human erythropoietin (rHuEPO) was effective, but the longer-acting darbepoetin alpha resulted in superior responses. In all animals, anaemia became progressive and more refractory across cycles because of accumulated bone marrow damage. Exploiting a specific enzyme-linked immunosorbent assay, which could distinguish between darbepoetin alpha and endogenous erythropoietin, the effect of CRT upon the pharmacokinetics of darbepoetin alpha showed that clearance of darbepoetin alpha, and presumably erythropoietin, was at least partially dependent on a chemotherapy-sensitive pathway. Scheduling data suggested that administration of erythropoietic agents prior to chemotherapy was more effective than administration after chemotherapy. There was no evidence that erythropoietic agents exacerbated anaemia, even when administered immediately prior to CRT in an attempt to 'prime' erythroid cells for the effects of CRT.

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Section: Discussionsupporting

confidence: 87%

Kinetics of haematopoietic recovery after dose‐intensive chemo/radiotherapy in mice: optimized erythroid support with darbepoetin alpha

et al. 2003

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“…A decrease in the doses, together with less frequent injections, reinforces the interest of treating CRF patients with darbepoetin, owing to a parallel reduction in morbidity and care costs. Previous studies have shown that darbepoetin can effectively maintain haemoglobin concentrations when given at extended dose intervals relative to r-HuEPO in dialysis subjects [15,[19][20][21]. The conversion index of 1 μg darbepoetin/200 U r-HuEPO appeared satisfactory in our population, while maintaining stable Hb concentrations in the switched group.…”

Section: Discussionmentioning

confidence: 49%

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

et al. 2007

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Darbepoetin alfa (DA) is a unique long-acting treatment for anaemia in patients with chronic renal failure (CRF). This study assessed the mean dose of DA to achieve and maintain haemoglobin (Hb) levels between 11 g/dl and 13 g/dl in CRF children aged 11 years to 18 years. This observational, prospective study was conducted in 39 patients treated with DA. Twenty-nine patients were switched from recombinant human erythropoietin (r-HuEPO), and ten patients were naive to r-HuEPO. Naive patients received initial doses of 0.45 μg/kg of DA. Switched patients received a dose adjusted to the prior dose of r-HuEPO (200 IU r-HuEPO:1 μg DA). Among the switched patients, 79.3% received dialysis. No naive patients underwent dialysis. Overall, 74% of patients showed increased Hb level, with a mean value of 11.6±1.6 g/dl, using a mean DA dose of 0.63±0.48 μg/kg per week, and 66.7% patients reached the Pediatr Nephrol (2007) target Hb level. Hb increased in naive patients from 9.5 (95% CI: 7.7, 11.4) to 11.7 (95% CI: 10.9, 12.6) g/dl and in switched patients from 11.1 (95% CI: 10.6, 11.5) to 11.5 (95% CI: 10.8, 12.2) g/dl). Higher doses of DA were needed in the "switched" than in the "naive" patients to maintain Hb levels over 11 g/dl, respectively 0.73 (95% CI: 0.54, 0.92) and 0.34 (95% CI: 0.16, 0.52) μg/kg per week. Our results indicate the doses of DA necessary to treat CRF patients aged 11 years to 18 years. DA was an effective treatment to stabilise CRF patients at extended dosing intervals.

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“…Thirty (83%) of those evaluable patients successfully maintained the target haemoglobin with no or minimal dose increased required to maintain the required hemoglobin concentration , while their conversion regimen was unsuccessful in 6 patients and was concluded that darbepoetin-alpha administered once monthly, maintained hemoglobin effectively and safely in most dialysis patients stabilized previously on once every 2 weeks dosing however the median weekly dose of darbepoetin-alpha increased from (15 units , CI =11. [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] at the start of the study to (21.88 units, CI =12. 31-31.25) .…”

Section: Discussionmentioning

confidence: 99%

“…Several studies indeed demonstrated that the interval of subcutaneous darbepoetin-alpha injections can be extended to 2 weeks in dialysis patients and up to 4 weeks in patients with chronic renal failure (4,5). Data from clinical trials suggest that switching CKD patients receiving once weekly rHuEPO to once every 2 weeks darbepoetin alpha maintains target hemoglobin (Hb) concentration (6)(7)(8) . However, there is little reported evidence, if any, of switching hemodialysis patients directly from fortnightly darbepoetin alfa dosing to monthly darbepoetin alfa.…”

Section: Introductionmentioning

confidence: 99%

Monthly Administration of Darbepoetin Alpha in Saudi Hemodialysis Patients: is it a Practical Regimen?

et al. 2010

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Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients

Abstract: Darbepoetin alfa maintains hemoglobin as effectively as rHuEPO, but with a reduced dose frequency.

Cited by 160 publications

References 19 publications

Kinetics of haematopoietic recovery after dose‐intensive chemo/radiotherapy in mice: optimized erythroid support with darbepoetin alpha

Kinetics of haematopoietic recovery after dose‐intensive chemo/radiotherapy in mice: optimized erythroid support with darbepoetin alpha

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

Monthly Administration of Darbepoetin Alpha in Saudi Hemodialysis Patients: is it a Practical Regimen?

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