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

Gan To Kagaku Ryoho. 1998 Jan;25(1):97-109.
[Article in Japanese]

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects*
  • Blood Urea Nitrogen
  • Cisplatin / adverse effects*
  • Creatinine / blood
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Glycoproteins / administration & dosage*
  • Humans
  • Kidney / drug effects*
  • Kidney Diseases / chemically induced
  • Kidney Diseases / drug therapy*
  • Kidney Diseases / physiopathology
  • Lung Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Trypsin Inhibitors / administration & dosage*

Substances

  • Antineoplastic Agents
  • Glycoproteins
  • Trypsin Inhibitors
  • Creatinine
  • urinastatin
  • Cisplatin