[Translation] A multicenter, open-label, single-arm Phase IIb clinical study to evaluate the safety and efficacy of MT1013 for injection in the treatment of patients with chronic kidney disease and secondary hyperparathyroidism receiving maintenance hemodialysis
主要研究目的
评价MT1013治疗接受维持性血液透析(MHD)的慢性肾脏病伴继发性甲状旁腺功能亢进(SHPT)患者的安全性。
次要研究目的
评价注射用 MT1013 治疗接受维持性血液透析(MHD)的慢性肾脏病伴继发性甲状旁腺功能亢进(SHPT)患者的有效性。
评价MT1013治疗接受维持性血液透析(MHD)的慢性肾脏病伴继发性甲状旁腺功能亢进(SHPT)患者的骨密度改善情况。
[Translation] Primary study objective
To evaluate the safety of MT1013 in the treatment of patients with chronic kidney disease and secondary hyperparathyroidism (SHPT) receiving maintenance hemodialysis (MHD).
Secondary study objective
To evaluate the effectiveness of MT1013 for injection in the treatment of patients with chronic kidney disease and secondary hyperparathyroidism (SHPT) receiving maintenance hemodialysis (MHD).
To evaluate the improvement of bone mineral density in patients with chronic kidney disease and secondary hyperparathyroidism (SHPT) receiving maintenance hemodialysis (MHD) treated with MT1013.