A MULTICENTER STUDY WITH ONCE A WEEK OR ONCE EVERY 2 WEEKS HIGH-DOSE SUBCUTANEOUS ADMINISTRATION OF RECOMBINANT-HUMAN-ERYTHROPOIETIN IN CONTINUOUS AMBULATORY PERITONEAL-DIALYSIS

Objective: To investigate the effectiveness of administering relativel y high doses of r-HuEPO subcutaneously once a week or once every 2 wee ks in patients undergoing continuous ambulatory peritoneal dialysis (C APD). 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 respons e was defined as a change in hematocrit (Ht) of 3% or more. Results we re 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: A fter 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 12000 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 i n the 9000 U group, and 10 (90.9%) of 11 in the 12000 U group maintain ed responses with the same dosing interval. There were no significant changes in mean blood pressure during the study period, and only 2 pat ients developed treatable hypertension with mild headache. Conclusion: Administration of relatively high doses of r-HuEPO to CAPD patients o nce a week or once every 2 weeks is safe and potentially an effective regimen for the correction of renal anemia.