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[Darbepoetin-alfa treatment of anemia secondary to chronic renal failure in dialysis patients: Results of a French multicenter study].

Abstract
Darbepoetin alfa is a unique genetically engineered glycoprotein with a three-fold longer terminal half-life than recombinant human erythropoietin (rHuEPO). The objective of this study was to determine if darbepoetin alfa administered at a reduced dosing frequency relative to the prior rHuEpo regimen is an effective and safe alternative for treating renal anemia in patients undergoing dialysis. A total of 1,008 French hemodialysis and peritoneal dialysis patients receiving stable rHuEPO therapy by either the intravenous (i.v., N = 217) or subcutaneous (s.c., N = 791) route were switched to darbepoetin alfa given by the same route of administration at a reduced dosing frequency. Patients receiving rHuEPO once weekly (N = 248, 25%) were switched to darbepoetin alfa every two weeks, and those receiving rHuEPO two or three times weekly (N = 760, 75%) were switched to darbepoetin alfa once weekly. The doses of darbepoetin alfa were titrated to maintain hemoglobin concentration in the target range of 10.0 to 13.0 g/dl for up to 24 weeks. The primary endpoint was the change in hemoglobin between baseline and the evaluation period (weeks 21-24). Adjusted (for covariates that might influence hemoglobin response) mean change in hemoglobin from baseline to the evaluation period was not clinically significant: +0.11 g/dl (95% CI: -0.30; 0.52). An i.v./s.c. dose ratio of 0.96 (95% CI: 0.86; 1.06) at evaluation confirms previous findings that darbepoetin alfa dose requirements were not different for the s.c. and i.v. routes. At the end of the evaluation period, more than 98% of patients successfully maintained hemoglobin within the target range and at their darbepoetin alfa assigned dosing frequency. Darbepoetin alfa was well tolerated with a safety profile consistent with that observed in previous darbepoetin alfa studies. Darbepoetin alfa administered at a reduced dosing frequency relative to the prior rHuEpo regimen effectively maintains hemoglobin in the target range in dialysis patients with renal anemia.
AuthorsMichèle Kessler, Thierry Hannedouche, Henry Fitte, Jean-Louis Cayotte, Pablo Urena, Jean-Christophe Réglier, Groupe de l'étude NESP 20000117
JournalNephrologie & therapeutique (Nephrol Ther) Vol. 2 Issue 4 Pg. 191-9 (Sep 2006) ISSN: 1769-7255 [Print] France
Vernacular TitleTraitement par la darbepoetin alfa de l'anémie liée à l'insuffisance rénale chronique chez les patients dialysés: résultats d'une étude multicentrique française.
PMID16966064 (Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study)
Chemical References
  • Hemoglobins
  • Erythropoietin
  • Darbepoetin alfa
Topics
  • Aged
  • Anemia (drug therapy, etiology)
  • Darbepoetin alfa
  • Erythropoietin (administration & dosage, analogs & derivatives)
  • Female
  • France
  • Hemoglobins (analysis)
  • Humans
  • Injections, Intravenous
  • Injections, Subcutaneous
  • Kidney Failure, Chronic (complications, therapy)
  • Male
  • Renal Dialysis (adverse effects)
  • Treatment Outcome

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