PMID- 17703832
OWN - NLM
STAT- MEDLINE
DCOM- 20071026
LR  - 20190608
IS  - 0301-0430 (Print)
IS  - 0301-0430 (Linking)
VI  - 68
IP  - 1
DP  - 2007 Jul
TI  - The first human cell line-derived erythropoietin, epoetin-delta (Dynepo), in the 
      management of anemia in patients with chronic kidney disease.
PG  - 26-31
AB  - AIMS: To evaluate the efficacy and safety of the first human cell line-derived 
      erythropoietin, epoetin-delta, in the management of anemia in patients with 
      chronic kidney disease. METHODS: This was a multicenter, randomized, 
      double-blind, parallel-group, active-control, Phase III study. Patients aged > or 
      = 18 years with chronic renal disease requiring hemodialysis, with hemoglobin 
      (Hb) levels in the range 9.6-12.4 g/dl, and who had been treated with recombinant 
      erythropoietin for > or = 90 days before study entry were eligible. In the 
      initial double-blind comparative study phase, patients were randomized in a 3:1 
      ratio to 24-week treatment with either intravenous (i.v.) epoetin-delta (ED) or 
      epoetin-alpha (EA). Patients then entered a 28-week open-label phase, receiving 
      i.v. ED at a dose equal to that of i.v. ED or EA which they received at the end 
      of the blinded phase. RESULTS: In total, 752 patients were randomized, of whom 
      555 patients subsequently received ED and 191 patients EA, with 583 patients 
      (77.5%) completing the double-blind phase and entering the open-label phase. 
      There was no significant difference between groups for the primary endpoint: the 
      average Hb level from Weeks 12-24 of the study. The adjusted mean average Hb 
      level for the modified intent-to-treat (mITT) population was 11.57 g/dl in the ED 
      group (n = 491, mean dose 63.5 IU/kg) and 11.56 g/dl in the EA group (n = 175, 
      mean dose 62.8 IU/kg). Efficacy was maintained on long-term use. Data for Weeks 
      12-52 show that ED maintained patients' Hb levels in the target range (10-12 
      g/dl) with a mean Hb level of 11.31 g/dl at a mean ED dose of 63.7 IU/kg. ED 
      therapy was well tolerated, with a similar overall incidence of adverse events 
      (AEs) (94.4%) to the EA group (92.1%) in the double-blind phase (most common 
      events: hypotension, upper respiratory tract infection, muscle cramps, headache). 
      AEs occurring during the open-label phase were generally similar in type and 
      frequency to those reported during the double-blind phase. CONCLUSIONS: The human 
      cell line-derived erythropoietin, epoetin-delta, provides an effective, well 
      tolerated new option for the management of anemia in patients with chronic kidney 
      disease.
FAU - Martin, K J
AU  - Martin KJ
AD  - Division of Nephrology, Saint Louis University, St. Louis, MO 63110, USA. 
      martinkj@slu.edu
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Clin Nephrol
JT  - Clinical nephrology
JID - 0364441
RN  - 0 (Recombinant Proteins)
RN  - 11096-26-7 (Erythropoietin)
RN  - 474EI5756Y (epoetin delta)
SB  - IM
MH  - Anemia/*drug therapy/*etiology
MH  - Cell Line
MH  - Chronic Disease
MH  - Double-Blind Method
MH  - Erythropoietin/*therapeutic use
MH  - Female
MH  - Humans
MH  - Kidney Diseases/*complications
MH  - Male
MH  - Middle Aged
MH  - Recombinant Proteins
EDAT- 2007/08/21 09:00
MHDA- 2007/10/30 09:00
CRDT- 2007/08/21 09:00
PHST- 2007/08/21 09:00 [pubmed]
PHST- 2007/10/30 09:00 [medline]
PHST- 2007/08/21 09:00 [entrez]
AID - 10.5414/cnp68026 [doi]
PST - ppublish
SO  - Clin Nephrol. 2007 Jul;68(1):26-31. doi: 10.5414/cnp68026.