[Translation] A single-center, open, randomized, parallel controlled clinical study on the safety and efficacy of oral CK15 soft capsules in the treatment of patients with chronic kidney disease stage 5 (hemodialysis) combined with secondary hyperparathyroidism
1. 评估口服不同剂量CK15软胶囊连续给药4周,治疗慢性肾脏病5期血液透析合并SHPT患者的安全性和有效性
2. 评价CK15软胶囊在慢性肾脏病5期血液透析患者中的PK特征
3. 为Ⅱ期临床试验确定给药方案和用药剂量提供依据
[Translation] 1. To evaluate the safety and efficacy of oral administration of different doses of CK15 soft capsules for 4 consecutive weeks in the treatment of patients with chronic kidney disease stage 5 undergoing hemodialysis and SHPT
2. To evaluate the PK characteristics of CK15 soft capsules in patients with chronic kidney disease stage 5 undergoing hemodialysis
3. To provide a basis for determining the dosing regimen and dosage for Phase II clinical trials