The purpose of the present study is to determine the change in blood concentration of interleukin-2 (IL-2) after intravenous injection in hemodialysis patients and to assess its safety. Four hemodialysis patients who underwent nephrectomy due to renal cell carcinoma were treated with IL-2 at a dose of 350 000-700 000 JRU by intravenous injection. Pharmacokinetic parameters were analyzed from the serum IL-2 concentration, which reached its peak just after the end of infusion, followed by biphasic elimination, and was below the detection limit in all patients at 24 h postinfusion. In comparison with patients with normal renal function, the volume of distribution in the serum compartment was almost comparable (3820 +/- 2020 mL). Clearance (50.47 +/- 11.50 mL/min) decreased to 40%, and the half-life of the distribution phase (0.45 +/- 0.19 h) and that of the terminal phase (1.72 +/- 0.20 h) were distinctly longer. The area under the blood concentration-time curve was about two-fold higher than that of non-hemodialysis patients. In all patients, there were no serious adverse reactions. The results of the present study suggest that intravenous IL-2 therapy can be safely performed in hemodialysis patients.
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