Secondary hyperparathyroidism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged >=18 years, regardless of gender; 2. Received maintenance hemodialysis treatment 3 times a week for at least 3 months, and hemodialysis treatment is expected to continue during the medication period; 3. 300 pg/ml= 3 months; 5. The dry weight is in the range of 45kg to 90kg (including 45kg and 90kg); 6. Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to vitamin D or its analogues; 2. Women who are pregnant or breastfeeding (consultation); those with fertility who are unwilling or unable to take effective contraceptive measures; 3. Those who are participating or participating in other drug clinical trials within 4 weeks before screening; 4. Patients with hypercalcemia (serum ionized calcium concentration >= 2.5 mmol/L); 5. Those with Kt/v<1.2 during the screening period; 6. Those who have had any evidence of malignant tumor within 1 year or received treatment for malignant tumor; 7. Any patient with active infection that requires systemic treatment in the past 3 weeks; 8. Thromboembolic events occurred recently (<3 months before screening), such as acute coronary syndrome, stroke, or VTE (except for dialysis access thrombosis); 9. Those who have undergone major surgery recently (<3 months before screening) or plan to undergo major surgery during the study period; 10. Have a history of alcohol abuse, illegal drugs, a history of major mental illness, or any history of drug abuse or addiction within 1 year before screening; 11. The researcher believes that it is not suitable to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intact parathyroid hormone, iPTH; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone-Specific Alkphase, b-ALP;Cross-Linked Carboxy-Terminal telopeptide of type I collagen, ß-CTX;myostatin, MSTN; | — |
Countries
China
Contacts
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine