| 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. |
| Authors | Michèle Kessler, Thierry Hannedouche, Henry Fitte, Jean-Louis Cayotte, Pablo Urena, Jean-Christophe Réglier, Groupe de l'étude NESP 20000117
(Affiliation: Service de néphrologie, CHU de Nancy-Brabois, 8, rue du Morvan, 54511 Vandoeuvre-Lès-Nancy cedex, France. m.kessler at chu-nancy.fr)
|
| Journal | Néphrologie & thérapeutique
(Nephrol Ther)
Vol. 2
Issue 4
Pg. 191-9
(Sep 2006)
ISSN: 1769-7255 France |
| Vernacular Title | Traitement par la darbepoetin alfa de l'anémie liée à l'insuffisance rénale chronique chez les patients dialysés: résultats d'une étude multicentrique française. |
| PMID | 16966064
(Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study)
|
| Chemical References |
- Hemoglobins
- Erythropoietin
- darbepoetin alfa
|
| Topics |
- Aged
- Anemia
(drug therapy, etiology)
- 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
|
