Secondary hyperparathyroidism in hemodialysis patients
Conditions
Interventions
Paricalcitol Group:Paricalcitol
Cinacalcet Group:Cinacalcet
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Need to sign informed consent form; 2. Patients >= 18 years of age with Stage 5 CKD; 3. Patients are receiving maintenance haemodialysis for >= 3 months(three times a week and Kt/V >= 1.2)before screening and were to continue haemodialysis throughout the designated study period; 4. Last iPTH: > 300pg/ml within 1 week before enrollment; 5. Last cCa concentration: 8.4mg/dl(2.1mmol/L) <= cCa concentration <= 10.0mg/dl (2.5mmol/L) within 1 week before enrollment; 6. Last P concentration <= 5.5mg/dl (1.78mmol/L) within 1 week before enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to vitamin D or its analogues. 2. Patients who are allergic to sinacase or any of its ingredients. 3. Patients with vitamin D poisoning (25 hydroxyvitamin D3 exceeds the upper limit of normal laboratory range). 4. Patients with high heart disease [New York Heart Association functional classification >= level III]. 5. Patients with existing malignant tumors. 6. Patients with active liver disease or abnormal liver function (alt, AST, TBIL are more than 3 times of the upper limit of normal value). 7. Patients with epilepsy risk or previous history. 8. Patients who have a history of gastrointestinal bleeding or peptic ulcer and have the possibility of recurrence or deterioration. 9. Patients who had parathyroid surgery within one year. 10. Patients expected or planned to undergo parathyroidectomy during the study period. 11. Patients expected or planned to receive kidney transplantation during the study period. 12. Patients with a history of alcohol and drug use. 13. Subjects who had used aluminum phosphorus binder for more than 3 weeks within 3 months before enrollment. 14. Subjects with life expectancy less than 1 year. 15. Lactation, pregnant women or planned pregnancy within one year. 16. Subjects who participated in clinical trials of other drugs or devices within 1 month before enrollment. 17. According to the judgment of the researcher, there are other subjects who are not suitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iPTH; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ca;P;Adverse events; | — |
Countries
China
Contacts
Public ContactLiu Zhangsuo / Wang Pei
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed