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

ABSTRACT

UNLABELLED MR-20 was administered to 140 lung cancer patients who presented with nephrotoxicity due to cisplatin (CDDP) treatment at 59 institutions throughout Japan during the period from September 1992 through March 1994 to study its suppressive effect on the nephrotoxicity as well as its safety. The results are reported in this paper. METHODS: The efficacy and usefulness of MR-20 were studied in a placebo-controlled, double-blind manner. An efficacy rate of 58.7% was achieved in the MR-20 group, and 36.8% in the placebo group MR-20 was significantly more effective for nephrotoxicity than placebo (U-test). Serum Cr, Ccr and FENa were prevented from significant variations in the MR-20 group, compared with the control group. It was considered that MR-20 is a safe drug, and that it is useful in suppressing the nephrotoxicity of CDDP treatment.