PMID- 7993190
OWN - NLM
STAT- MEDLINE
DCOM- 19950106
LR  - 20190830
IS  - 0160-564X (Print)
IS  - 0160-564X (Linking)
VI  - 18
IP  - 8
DP  - 1994 Aug
TI  - Differences in intravenous and subcutaneous application of recombinant human 
      erythropoietin: a multicenter trial.
PG  - 552-8
AB  - The aims of this clinical study were to compare the maintenance doses for 
      intravenous (i.v.) and subcutaneous (SC) administration of recombinant human 
      erythropoietin (rhEPO) and to investigate whether there is any difference in the 
      increase of the packed cellular volume (PCV) per week under i.v. and SC 
      administration of rhEPO from two production sites (Genetics Institute, Cambridge, 
      USA; and Boehringer Mannheim, Penzberg, Germany). A total of 90 patients 
      suffering from end-stage renal disease were included in the study. All patients 
      had already been treated for at least 6 months with chronic hemodialysis. The 
      study was carried out as a randomized, multicenter parallel group comparison 
      study with a 1-week pretreatment phase, a subsequent 8-week double-blind phase, 
      and a final open phase. The final open phase consisted of a correction phase and 
      a maintenance phase. The production site had no influence on the PCV increase per 
      week, and there were no differences with respect to tolerability. The median 
      rhEPO dose required to maintain the target PCV of 30 to 35 vol.% was 33 U/kg body 
      weight three times a week in the i.v. group compared with 22 U/kg in the SC group 
      (i.e., an average of 30% less with SC administration). Development or aggravation 
      of hypertension under rhEPO therapy was observed, especially during the 
      correction phase and more frequently in the SC group than in the i.v. group. 
      During the maintenance phase, there was no essential difference between the two 
      groups.
FAU - Schaller, R
AU  - Schaller R
AD  - Klinik fur Innere Medizin, Friedrich-Schiller-Universitat, Jena, Germany.
FAU - Sperschneider, H
AU  - Sperschneider H
FAU - Thieler, H
AU  - Thieler H
FAU - Dutz, W
AU  - Dutz W
FAU - Hans, S
AU  - Hans S
FAU - Voigt, D
AU  - Voigt D
FAU - Marx, M
AU  - Marx M
FAU - Engelmann, J
AU  - Engelmann J
FAU - Schoter, K H
AU  - Schoter KH
FAU - Scigalla, P
AU  - Scigalla P
AU  - et al.
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Artif Organs
JT  - Artificial organs
JID - 7802778
RN  - 0 (Recombinant Proteins)
RN  - 11096-26-7 (Erythropoietin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Analysis of Variance
MH  - Anemia/blood/etiology/therapy
MH  - Double-Blind Method
MH  - Erythropoietin/*administration & dosage/adverse effects/biosynthesis
MH  - Female
MH  - Germany
MH  - Hematocrit
MH  - Humans
MH  - Hypertension/etiology
MH  - Injections, Intravenous
MH  - Injections, Subcutaneous
MH  - Kidney Failure, Chronic/complications/therapy
MH  - Male
MH  - Middle Aged
MH  - Recombinant Proteins/administration & dosage/adverse effects/biosynthesis
MH  - Renal Dialysis
EDAT- 1994/08/01 00:00
MHDA- 1994/08/01 00:01
CRDT- 1994/08/01 00:00
PHST- 1994/08/01 00:00 [pubmed]
PHST- 1994/08/01 00:01 [medline]
PHST- 1994/08/01 00:00 [entrez]
AID - 10.1111/j.1525-1594.1994.tb03378.x [doi]
PST - ppublish
SO  - Artif Organs. 1994 Aug;18(8):552-8. doi: 10.1111/j.1525-1594.1994.tb03378.x.