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

Abstract

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.