Secondary Hyperparathyroidism (SHPT)
Conditions
Interventions
Severe SHPT:Administer Cinacalet HCL tablet to subjects from 1st to 32nd week. Subjects choose to buy and take Cinacalcet HCL tablet from 33rd to 52nd week.
Moderate SHPT:Administer Cinacalet HCL tablet to subjects from 1st to 32nd week. Subjects choose to buy and take Cinacalcet HCL tablet from 33rd to 52nd week.
Mild SHPT:Administer Cinacalet HCL tablet to subjects from 1st to 32nd week. Subjects choose to buy and take Cinacalcet HCL tablet from 33rd to 52nd week.
Sponsors
Nanjing Jinling Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Parents/guardians signed informed consent; 2. Aged 18 to 75 years males or females; 3. Clinically diagnose: Hemodialysis CKD patients with SHPT; 4. Screening period: iPTH=300Pg/ml; 5. Patients did not receive Calcimimetics (for example, Cinacalcet) within 6 months before enrollment; 6. Patients have been on maintenance HD 3 times weekly (TIW) for at least 3 months(12 weeks) prior to enrollment and are expected to remain on HD for the duration of the study; 7. Expected survival = 2 years.
Exclusion criteria
Exclusion criteria: 1. Patients with hypocalcemia; [Corrected Calcium concentration in serum Ca2+ <2.1mmol/L(8.4mg/dL). 2. Patients with a history of gastrointestinal bleeding or previous history of peptic ulcer and there may be a symptom of deterioration or recurrence; 3. Patients with severe heart disease; 4. Patients with epilepsy risk or previous history of epilepsy; 5. Patients with hypersensitivity to Cinacalcet; 6. Patients with drug abuse/addiction; 7. Patients who are going to receive renal transplantation surgery within 52 weeks after enrollment 8. Pregnancy (blood or urine pregnancy test is positive) or lactating women 9. Men or women with a pregnancy plan within 1 years; or if the patient is not guaranteed to take effective contraceptive measures (condoms or birth control pills, etc.) within 1 year after the entry into the group; 10. Patients participated in other clinical trials within 4 weeks prior to enrollment; 11. Patients received parathyroidectomy within 24 weeks prior to enrollment; 12. Judged by investigator, patients who are not suitable to participate in this study due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients reaching iPTH target at 20th week & 32nd week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week;Compared with baseline data, the proportion of patients with = 30% reduction in iPTH level at 20th week & 32nd week;The proportion of patients reaching iPTH target during 1~32 weeks & 33~52 weeks;Compared with baseline data, the changes of Ca × P, ALP and FGF-23 at 20th week and at 32nd week;Compared with baseline data, the adjustment (type or amount) of calcium, phosphate binders, vitamin D and its analogues and diphosphonic acid salts combined medication;Compared with the data of 32nd week, the changes of proportions of patients reaching iPTH, Ca, P & Ca × P target who continue & discontinue Cinacalcet treatment after 20-week real world;Type and amount of medicine which were used by patients for CKD-MBD management & the reasons of patients discontinuing Cinacalcet in 20-week real world; | — |
Countries
China
Contacts
Public ContactLiu Zhihong
Nanjing Jinling Hospital
Outcome results
None listed