Pharmacokinetics of Recombinant Human Erythropoietin in Patients on Continuous Ambulatory Peritoneal Dialysis

Macdougall, I. C.; Neubert, Peter; Coles, G A; Roberts, D E; Dharmasena, Aruna; Williams, J. D.

doi:10.1016/s0140-6736(89)90014-7

Cited by 150 publications

(60 citation statements)

References 9 publications

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“…The absolute bioavailability found in our pilot study after SC rHuEPO administration was in the range reported in adult patients with end-stage renal disease (21%-36%) [11,14,27]. In a recent paediatric study, it ranged between 21% and 60% with a mean of 40%.…”

Section: Discussionsupporting

confidence: 72%

“…300 units/kg (vs. 133 units/kg in our series), was given to adult CAPD patients, resulting in mean AUC and Cmax values which were about twice as high as in our patients. Macdougall et al [11], who gave an rHuEPO dose (120 units&g) similar to that used in our study, observed a comparable mean AUC, but mean Cmax was only 176 units/l and mean EPO levels remained above the baseline up to 96 h. Stockenhuber et al [27], who injected 100 units rHuEPO/kg to adult patients on dialysis, reported Cmax and AUC values less than half of those observed in this study. In these studies, however, tl/2 was similar to our findings.…”

Section: Discussionsupporting

confidence: 72%

“…Correspondence to: K. Scharer, Sektion ftir p~idiatrische Nephrologie, Universit~its-Kinderklinik Heidelberg, Im Neuenheimer Feld 150, D-6900 Heidelberg, Germany After IV administration to adult patients with CRF, the elimination half-life (tl/2) of rHuEPO is relatively short (5-12 h) compared with that following SC application [11][12][13][14]. This route may be preferable to the IV route, allowing less frequent application and injections at home.…”

Section: Introductionmentioning

confidence: 99%

“…This route may be preferable to the IV route, allowing less frequent application and injections at home. In adults with CRF maintained on SC rHuEPO, the drug appears to be more effective than when given IV, despite the lower bioavailability [11,13,15,16]. For children, SC administration appears to be of special benefit in preterminal CRF and during continuous ambulatory peritoneal dialysis (CAPD) [4,9], where a permanent vascular access is not available.…”

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetics of recombinant human erythropoietin applied subcutaneously to children with chronic renal failure

et al. 1993

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Abstract. The single-dose pharmacokinetics of recombinant human erythropoietin (rHuEPO) given SC was investigated in 20 patients aged 7-20 years at different stages of chronic renal failure. In a pilot study we confirmed the lower bioavailability of the drug in 2 children when given SC compared with the IV route (24% and 43%, respectively). Following administration of 4,000 units/m2, rHuEPO SC effective serum erythropoietin concentrations increased from a mean baseline level (_+ SD) of 23 ___ 13 units/1 to a mean peak concentration of 265 _+ 123 units/l, which was reached after 14.3 ___ 9.4 h, followed by a slow decline until baseline values were attained at 72 h. Mean residence time was 30 +9 h and mean elimination halftime 14.3 +7 h. The single-dose kinetics of SC rHuEPO in children with different degrees of renal failure are comparable to those in adult patients. Possibly, the higher efficacy of SC rHuEPO in patients with renal anaemia compared with IV rHuEPO is related to its prolonged action.

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Section: Discussionsupporting

confidence: 72%

Section: Discussionsupporting

confidence: 72%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetics of recombinant human erythropoietin applied subcutaneously to children with chronic renal failure

et al. 1993

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“…In addition, the depletion of responding erythroid precursors by the cytotoxic effects of chemotherapy may result in a higher dosing requirement than is needed in the setting of renal failure. Although the pharmacokinetics of rHuEPO in dialysis patients have been described, no such report exists for the pharmacokinetics of rHuEPO in patients with cancer (Macdougall et al, 1989). The current study was undertaken to evaluate the pharmacokinetic profile of NESP administered to cancer patients receiving multiple cycles of chemotherapy and to compare the pharmacokinetics of single-and multiple-dose administration of NESP through 3 cycles of chemotherapy.…”

mentioning

confidence: 99%

Pharmacokinetics of novel erythropoiesis stimulating protein (NESP) in cancer patients: preliminary report

2001

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Anaemia is a common occurrence in patients with cancer, and currently can be treated in several ways. Novel erythropoiesis stimulating protein (NESP, darbepoetin alfa) was created using site-directed mutagenesis to have 8 more sialic acid side chains than recombinant human erythropoietin (rHuEPO). The additional sialic acid content has resulted in an approximately 3-fold greater half-life relative to rHuEPO in patients with chronic renal failure. This study evaluates the pharmacokinetic profile of NESP in patients receiving multiple cycles of chemotherapy. Anaemic patients (haemoglobin ≤ 11.0 g dl −1 ) who had non-myeloid malignancies received NESP weekly (2.25 mcg kg −1 wk −1 ) under the supervision of a physician, starting on day 1 of chemotherapy for 3 chemotherapy cycles given at 3-week intervals. Blood samples were collected during chemotherapy cycles 1 and 3 for pharmacokinetic analysis. All patients were followed for 4 weeks after treatment. NESP was well tolerated by all patients. After a single dose during chemotherapy cycle 1, pharmacokinetic parameters (mean (SD), n ) for the first 15 patients were: T max 86.1 (22.8) h ( n = 14); C max 9.0 (5.1) ng ml −1 ( n = 14); t 1/2,z 32.6 (11.8) h ( n = 7); CL/F 3.7 (1.0) ml h −1 kg −1 ( n = 7). The subjects for whom all parameters could be calculated may represent a sub-group of the entire population. Similar results were obtained in cycle 3. In addition, haemoglobin response data suggests that, in this patient population, dosing less frequently than the 3 times weekly doses used for rHuEPO may be possible while improving anaemia. © 2001 Cance Cancer Research Campaign

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