A multicenter study with once a week or once every two weeks high-dose subcutaneous administration of recombinant human erythropoietin in continuous ambulatory peritoneal dialysis.
OBJECTIVE
To investigate the effectiveness of administering relatively high doses of r-HuEPO subcutaneously once a week or once every 2 weeks in patients undergoing continuous ambulatory peritoneal dialysis (CAPD).


METHODS
Multicenter prospective analysis. The trial was divided into two phases: an initial 8-week phase (once a week dosing) followed by a 12-week maintenance phase (once every 2 weeks dosing). A response was defined as a change in hematocrit (Ht) of 3% or more. Results were analyzed using Sheffe's test, Mantel-Haenszel's test, and Dunnett's test.


METHODS
Eleven renal units in Japan providing a CAPD program.


METHODS
Forty-one CAPD patients with a Ht of 28% or less.


RESULTS
After the initial 8 weeks, 13 (81.3%) of 16 patients showed a response to 6000 U (106.9 +/- 20.0 U/kg) subcutaneously (sc), once a week. Eleven (84.6%) of 13 in the 9000 U (166.5 +/- 27.7 U/kg) group and all 12 (100%) in the 12,000 U (210.7 +/- 42.1% U/kg) group also showed responses. At the end of both phases, that is, at 20 weeks, 7 (53.8%) of 13 patients in the 6000 U group with once every 2 weeks dosing, 7 (63.6%) of 11 in the 9000 U group, and 10 (90.9%) of 11 in the 12,000 U group maintained responses with the same dosing interval. There were no significant changes in mean blood pressure during the study period, and only 2 patients developed treatable hypertension with mild headache.


CONCLUSIONS
Administration of relatively high doses of r-HuEPO to CAPD patients once a week or once every 2 weeks is safe and potentially an effective regimen for the correction of renal anemia.
Nomoto
Y
Y
Department of Internal Medicine, School of Medicine, Tokai University, Isehara City, Japan.
Kawaguchi
Y
Y
Kubota
M
M
Tagawa
H
H
Kubo
K
K
Ogura
Y
Y
Shoji
T
T
Kawada
Y
Y
Koshikawa
S
S
Mimura
N
N
D000328:Adult; D000740:Anemia / Q000188:drug therapy; D001794:Blood Pressure / Q000187:drug effects; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D006400:Hematocrit; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000379:methods; D011446:Prospective Studies; D011994:Recombinant Proteins
D011994:Recombinant Proteins; D004921:Erythropoietin