Randomized trial to compare the dosage of darbepoetin alfa by administration route in haemodialysis patients

• Published in: Nephrology (Carlton, Vic.) Vol. 14; no. 5; pp. 482 - 487
• Main Authors: KIM, CHAN-DUCK, PARK, SUN-HEE, KIM, DAE-JOONG, PARK, JONG-WON, DO, JUN-YOUNG, SHIN, SUK-KYUN, KIM, BEOM-SEOK, SEO, JUNG-JU, KIM, YONG-LIM
• Format: Journal Article
• Language: English
• Published: Melbourne, Australia Blackwell Publishing Asia 01.08.2009
• Subjects: administration route; anaemia; Anemia - drug therapy; Darbepoetin alfa; Erythropoietin - administration & dosage; Erythropoietin - analogs & derivatives; haemodialysis; Hemoglobins - analysis; Humans; Injections, Intravenous; Injections, Subcutaneous; Prospective Studies; recombinant human erythropoietin; Renal Dialysis
• ISSN: 1320-5358; 1440-1797
• DOI: 10.1111/j.1440-1797.2008.01067.x

SUMMARY Aim:  The doses of darbepoetin alfa required to maintain target haemoglobin levels after s.c. or i.v. administration when recombinant human erythropoietin (rHuEpo) treatment was replaced by darbepoetin alfa treatment in haemodialysis (HD) patients were compared. Methods:  In this prospective, randomized, open‐label study, 65 HD patients who were receiving stable SC doses of rHuEpo were switched to an equivalent dose of darbepoetin alfa at a reduced frequency by s.c. or i.v. administration. Patients were randomly assigned to the s.c. group (n = 32) or the i.v. group (n = 33). Darbepoetin alfa doses were titrated to maintain target haemoglobin levels of 8.0–11.0 g/dL for up to 24 weeks. A period of 20 weeks was used for dose titration and haemoglobin stabilization. This was followed by a 4 week evaluation period. Results:  The mean haemoglobin concentration during the evaluation period was similar in the s.c. and i.v. groups. The mean dose and mean weight‐standardized dose of darbepoetin alfa during the evaluation period tended to be lower in the s.c. group than the i.v. group, although these differences were not statistically significant. The mean weekly darbepoetin alfa dose requirements during the evaluation period significantly decreased in both groups compared to the dose requirements at randomization. Conclusion:  There is a possibility that s.c. administration of darbepoetin alfa is more efficacious than i.v. administration, but a definite benefit cannot be demonstrated with the current sample size. A bigger sample size is needed to confirm the result.