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A multicenter study with once a week or once every two weeks high-dose subcutaneous administration of recombinant
Y Nomoto1, Y Kawaguchi, M Kubota
1Department of Internal Medicine, School of Medicine, Tokai University, Isehara City, Japan.
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).
Design:
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.
Setting:
Eleven renal units in Japan providing a CAPD program.
Patients:
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.
Conclusion:
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.