[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the safety and efficacy of oral recombinant oxalate decarboxylase powder in patients with secondary hyperoxaluria
主要目的: 评价重组草酸脱羧酶散在继发性高草酸尿症患者中的有效性; 次要目的: 评价重组草酸脱羧酶散在继发性高草酸尿症患者中的安全性; 评价重组草酸脱羧酶散对继发性高草酸尿症患者血浆甲酸(草酸代谢物)浓度的影响; 评价重组草酸脱羧酶散在继发性高草酸尿症患者中的药代动力学(PK)特征。
[Translation] Primary objective: To evaluate the effectiveness of recombinant oxalate decarboxylase powder in patients with secondary hyperoxaluria; Secondary objective: To evaluate the safety of recombinant oxalate decarboxylase powder in patients with secondary hyperoxaluria; To evaluate the effect of recombinant oxalate decarboxylase powder on the plasma formic acid (oxalate metabolite) concentration in patients with secondary hyperoxaluria; To evaluate the pharmacokinetic (PK) characteristics of recombinant oxalate decarboxylase powder in patients with secondary hyperoxaluria.