Article ; Online: C.E.R.A. maintains stable control of hemoglobin in patients with chronic kidney disease on dialysis when administered once every two weeks.
American journal of nephrology
2008 Volume 28, Issue 2, Page(s) 280–289
Abstract: Background/aims: This Phase III study examined the efficacy and safety of C.E.R.A., a continuous ... TIW)), or receive C.E.R.A. Q2W by the same route as previous epoetin treatment for 36 weeks. Dosage ... Results: Mean change in Hb for C.E.R.A. and epoetin was 0.088 and -0.030 g/dl, respectively (endpoint Hb ...
Abstract | Background/aims: This Phase III study examined the efficacy and safety of C.E.R.A., a continuous erythropoietin receptor activator, given once every 2 weeks (Q2W) via subcutaneous or intravenous injection using pre-filled syringes, for maintaining hemoglobin (Hb) levels in patients with chronic kidney disease (CKD) on dialysis who converted directly from epoetin therapy. Methods: Patients (n = 336) were randomized 1:1 to continue epoetin at their current dose, route and administration interval (once to three times weekly (QW-TIW)), or receive C.E.R.A. Q2W by the same route as previous epoetin treatment for 36 weeks. Dosage was adjusted to maintain patients' Hb within +/-1.0 g/dl of baseline value and within 10.0-13.5 g/dl. Primary endpoint was mean change in Hb between baseline and the evaluation period (weeks 29-36). Results: Mean change in Hb for C.E.R.A. and epoetin was 0.088 and -0.030 g/dl, respectively (endpoint Hb 11.93 and 11.86 g/dl, respectively). Analysis showed that C.E.R.A. was as effective as epoetin in maintaining Hb (p < 0.0001), and was well tolerated. The administration route had no impact on primary endpoint. Conclusion: Q2W C.E.R.A. administered using pre-filled syringes effectively maintains stable control of Hb in patients on dialysis who convert directly from epoetin QW-TIW. |
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MeSH term(s) | Adult ; Aged ; Drug Administration Schedule ; Epoetin Alfa ; Erythropoietin/administration & dosage ; Erythropoietin/therapeutic use ; Female ; Hemoglobins/metabolism ; Humans ; Injections, Intravenous ; Kidney Failure, Chronic/therapy ; Male ; Middle Aged ; Polyethylene Glycols/administration & dosage ; Polyethylene Glycols/therapeutic use ; Recombinant Proteins ; Renal Dialysis/methods ; Syringes ; Treatment Outcome |
Chemical Substances | Hemoglobins ; Recombinant Proteins ; continuous erythropoietin receptor activator ; Erythropoietin (11096-26-7) ; Polyethylene Glycols (30IQX730WE) ; Epoetin Alfa (64FS3BFH5W) |
Language | English |
Publishing date | 2008 |
Publishing country | Switzerland |
Document type | Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't |
ZDB-ID | 604540-6 |
ISSN | 1421-9670 ; 0250-8095 |
ISSN (online) | 1421-9670 |
ISSN | 0250-8095 |
DOI | 10.1159/000111115 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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