Darbepoetin-alfa in renal-transplant patients: an observational monocentric study.
BACKGROUND
Anemia, frequent in post-transplant patients, has been associated with cardiovascular outcomes. Although recombinant human erythropoietin (rHuEPO) is used in post-transplant anemic patients, little information is available concerning the use of darbepoetin-alfa (DA) in this population.


METHODS
Eligible patients had been recipients of a kidney graft for > 3 months, had anemia and chronic renal failure, but no iron deficiency. 38 patients, not previously treated by rHuEPO (Group 1), were given DA, and 35 rHuEPO-treated patients (Group 2) were switched to DA according to European Summary of Product Characteristics. Only the subcutaneous route was used. Dose adjustments were done to maintain Hb at 11 - 13 g/dl. Hb levels and DA dosage were assessed at baseline, and at Months 3 and 6.


RESULTS
Mean age (A+/- SD) of patients was 47.7 (A+/- 13.4) years (53% male). Mean duration of transplantation was 8.5 (A+/- 5.5) years and mean creatinine clearance was 42.5 (A+/- 19.8) ml/min. In Group 1, mean Hb became increased by +1.27 g/dl (95% CI 0.61, 1.94) and mean DA dose was decreased by 44% between baseline and M6. In Group 2, mean Hb and DA dose remained stable between baseline and M6. Hb response to DA appeared faster in patients who had received a transplant for less than 3 years, and lower in patients who had received a transplant more than 12 years previously.


CONCLUSIONS
DA effectively corrected anemia in renal-transplant patients, in previously treated patients and in EPO-naive patients. DA was also found to be well-tolerated.
Ribes
D
D
Nephrology and Kidney Transplantation Department, CHU Rangueil, Toulouse University Hospital, France.
Kamar
N
N
Guitard
J
J
Esposito
L
L
Rostaing
L
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D003404:Creatinine / Q000097:blood; D000068256:Darbepoetin alfa; D004305:Dose-Response Relationship, Drug; D004921:Erythropoietin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006397:Hematinics / Q000008:administration & dosage / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007279:Injections, Subcutaneous; D007676:Kidney Failure, Chronic / Q000097:blood / Q000601:surgery*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D003404:Creatinine