Secondary hyperparathyroidism in hemodialysis patients
Conditions
Sponsors
Renji Hospital, Shanghai Tiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients are receiving maintenance hemodialysis for >= 3 months, three times a week,four hours at a time, dialysate calcium concentration is 1.5 mmol/L(dCa^2+ 1.5), and the dialysis regimen remained unchanged during the study period; 3. Serum iPTH (centralized detection) at the end of the elution period was > 400 pg/mL; 4. Average serum phosphorus level during elution (centralized detection) was 0.8-2.2 mmol/L (2.5-6.9 mg/dl); 5. Average corrected serum calcium level during elution period (centralized detection) <= 2.6 mmol/L (10.5 mg/dl); 6. Voluntarily participate in clinical trials and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Treatment with bisphosphonate, dinoselmer, or tripagotide was performed within 24 weeks prior to screening; 2. During the elution period, vitamin D and its analoges, calcium-like agents and non-calcium-phosphorus binding agents were administered; 3. The life expectancy of advanced malignant tumor is less than 1 year; 4. Patients with a history of uncontrolled diabetes(defined as a fasting blood glucose above 15 mmol/L after long term hypoglycemic measures); 5. History of refractory hypertension (defined as systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg after taking antihypertensive drugs); 6. Patients with severe heart disease (acute myocardial infarction, cardiogenic shock, acute heart failure, or chronic congestive heart failure (NYHA grade >= III); 7. History of severe arrhythmia or current treatment with antiarrhythmic drugs; 8. Patients with severe pulmonary insufficiency; 9. History of liver disease or current severe liver disease (ALT, AST, TBIL > 2 x ULN); 10. Acute infectious diseases, acute brain diseases, acute gastrointestinal bleeding history; 11. Participants who had received or planned to receive parathyroid intervention, parathyroidectomy, or kidney transplantation during the study period; 12. Participation with other clinical investigators within 3 months prior to screening; 13. Allergic to calcitol or vitamin D and its analogues or excipients in preparations (water for injection, disodium edTA, disodium hydrogen phosphate, polysorbide 20 and di-tert-butylp-cresol); a history of two or more severe drug allergies (e.g., anaphylactic shock); or prone to rash, urticaria and other allergic constitution; 14. Women who were breastfeeding, pregnant or not using effective contraception during the study period; 15. Patients considered unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iPTH(intact parathyroid hormone); | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum calcium;Serum phosphorus;Adverse events; | — |
Countries
China
Contacts
Public ContactNi Zhaohui
Renji Hospital, Shanghai Tiaotong University School of Medicine
Outcome results
None listed