[Early phase II study of FK352 in cisplatin-induced nephropathy. Niigata Prefecture FK352 Study Group].

: Early phase II study of FK352, a novel adenosine A1 antagonist, in cisplatin-induced nephropathy was conducted at 7 institutions in Niigata. Patients with non-small-cell lung cancer under CVM chemotherapy including cisplatin were enrolled. We evaluated the safety and efficacy of FK352 in comparison with those of mannitol in a randomized open trial. It is suggested that the diuretic effect of FK352 is based on its natriuresis and that the potency is equal to mannitol. In addition, FK352 tended to suppress the increase in urine beta-2 microglobulin, which suggests that FK352 ameliorated the cisplatin-induced tubular damage. No serious adverse event was observed with this drug. In conclusion, it is considered that FK352 shows a diuretic effect based on natriuresis with minimal adverse effect and that it exerts a beneficial effect on the prevention of cisplatin-induced nephropathy.