Secondary Hyperparathyroidism in patients with chonic kidney disease on dialysis
Conditions
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Adults of both genders between the ages of 18 and 75. 2)Patients with chronic kifney disease, had been on hemodialysis for at least three months and had stable hemodialysis protocol(Three times per week, four hours each time, dialysate calcium concentration tendency for 1.5mmol/L) ;the hemodialysis protocol shouldn't be changed significantly during the research. 3)Had intact PTH value of > 400 pg/mL at the end of washout period. 4)Had an average serum Phos in the range of 0.8-2.2 mmol/L(2.5-6.9mg/dL) during washout period.. 5)Had an average serum calcium of =2.6 mmol/L(10.5mg/dL)during washout period. 6)The patients agree to take the effective contraceptive measures,and avoid personal and their partners' pregnancy; 7)The patients should be able to keep good communication with researchers, and fully understand the purpose, process and risks of research, and agree to abide by the requirements of clinical trials and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients with allergic constitution, who prone to rash and urticaria and are allergic to active ingredient of the drug or ingredients of agents; or who have two or more serious drug allergy history(such as:ananphylacyic shock); 2)Had treatment with diphosphonate,teriparatide and denosumab within 24 weeks prior screening; 3)Had treatment with vitamine D and its analogs and calcimimetics; 4)Patients whose life expectancy are less than 1 year; 5)Had a history of hard to control diabetes (defined as Glycosylated hemoglobin higher than 9.5 percent after taking long-term hypolycemic measures); 6)Had resistant hypertension history(defined as systolic blood pressure higher than 180 MMHG or diastolic blood pressure higher than 110MMHG); 7)Patients who with severe heart disease, such as acute myocardial infarction, cardic shock, acute heart failure, or chronic congestive heart failure(NYHA class three or higher class); 8)Had severe arrrhythmia history; 9)Had severe pulmonary dysfunction; 10)Patients who had severe liver disease(ALT,AST,TBIL higher than twice the upper limit of normal); 11)Had one or more of test results of HIV-Ab,HBsAg,HCV-Ab,TP-Ab are positive within six manths; 12)Had acute infectious diseases, acute brain diseases, acute gastrointestinal bleeding; 13)Had received or planed to received parathyroid intervention, parathyroid gland resection or kidney transplants during the research; 14)Patients who had participated in other clinical trials and received durg or instruments interventions; 15)Women who are breastfeeding, pregant or unable to use effetive contraceptives during the research; 16)The investigator determined that the subjects had other conditions that made them ineligible to participate in the research.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| serum calcium;serum phosphorus; | — |
Primary
| Measure | Time frame |
|---|---|
| intact parathyroid hormone; | — |
Countries
China
Contacts
Public ContactHuijuan Mao
The First Affiliated Hospital With NanJing Medical University(Jiangsu Province Hospital)
Outcome results
None listed