|
MechanismHSP70 heat-shock proteins inhibitors |
|
|
|
|
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项在慢性肾脏病接受维持性透析的高磷血症患者中评价 AP301控制血清磷的有效性和安全性的随机、开放性、多中心 III 期研究
[Translation] A randomized, open-label, multicenter phase III study evaluating the efficacy and safety of AP301 in controlling serum phosphorus in hyperphosphatemia patients with chronic kidney disease receiving maintenance dialysis
主要目的
1. 评估 AP301 维持剂量组对透析高磷血症患者血清磷的控制是否优于AP301 低剂量对照组。
2. 评估 AP301 组对透析高磷血症患者血清磷的控制是否非劣于碳酸司维拉姆组。 次要目的
有效性:
1. 评估 AP301 对透析高磷血症患者血清磷控制的综合疗效。
2. 评估 AP301 对透析高磷血症患者血清钙、钙磷乘积(Ca×P)和全段甲状旁腺激素(iPTH)水平变化的影响。
安全性:
1. 评估 AP301 在透析高磷血症患者中的安全性和耐受性。
[Translation] main purpose
1. To evaluate whether the AP301 maintenance dose group is better than the AP301 low-dose control group in controlling serum phosphorus in patients with dialysis hyperphosphatemia.
2. To assess whether the AP301 group is non-inferior to the sevelamer carbonate group in controlling serum phosphorus in patients with hyperphosphatemia on dialysis. secondary purpose
Validity:
1. To evaluate the comprehensive efficacy of AP301 on serum phosphorus control in patients with hyperphosphatemia on dialysis.
2. To evaluate the effect of AP301 on the changes of serum calcium, calcium phosphate product (Ca×P) and intact parathyroid hormone (iPTH) levels in patients with hyperphosphatemia on dialysis.
safety:
1. To evaluate the safety and tolerability of AP301 in patients with hyperphosphatemia on dialysis.
100 Clinical Results associated with Libang Biomedical (Jiangsu) Co., Ltd.
0 Patents (Medical) associated with Libang Biomedical (Jiangsu) Co., Ltd.
100 Deals associated with Libang Biomedical (Jiangsu) Co., Ltd.
100 Translational Medicine associated with Libang Biomedical (Jiangsu) Co., Ltd.