[A clinical phase II trial of ulinastatin (MR-20) for nephrotoxicity of cisplatin]

MR-20 was administered to 37 lung cancer patients who presented with nephrotoxicity due to cisplatin (CDDP) treatment in an 11-institution cooperative trial during the period from September 1990 through March 1992 to study its suppressive effect on the nephrotoxicity as well as its safety. The results are reported in this paper.

MR-20 was administered at 3 daily doses, ie. 150,000, 300,000 and 600,000 units, in a nonblind manner. An efficacy rate of 27.3% was achieved in the group at 150,000 units; 44.4% in the group at 300,000 units; and 45.5% in the group at 600,000 units. Serum Cr levels remained significantly lower in the group at 300,000 units during the treatment period than in the screening period. No adverse reactions to MR-20 were observed. According to the above results, it was anticipated that MR-20 would suppress the nephrotoxicity of CDDP treatment and be safe, and that the drug at a dose of 300,000 units daily would be useful in suppressing the nephrotoxicity.