Chronic Kidney Disease
Conditions
Interventions
Experimental group:Low calcium dialysate
Control group:High calcium dialysate
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Prior to any assessment, written informed consent must be obtained. 2. Male or female patients over 18 years old in China. 3. Maintenance hemodialysis for more than 3 months, dialysis program (including HD and HDF) is stable, the frequency was 3 times a week. 4. Serum phosphorus > 1.78 mmol/L without hypocalcemia. 5. Coronary artery calcification was found in coronary CT examination.
Exclusion criteria
Exclusion criteria: 1. Patients who planned kidney transplantation or changed to peritoneal dialysis in recent 6 months. 2. Currently clinically significant gastrointestinal (GI) diseases, including gastrointestinal bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, history of intestinal obstruction, history of gastrectomy or duodenectomy; newly diagnosed peptic or duodenal ulcer diseases within 4 weeks before screening. 3. 6 months before screening, patients had a history of cerebrovascular disease or cardiovascular disease, hospitalized due to stroke, myocardial infarction, unstable angina pectoris, congestive heart failure, severe valve stenosis, uncontrolled atrial fibrillation and uncontrolled arrhythmia, QT interval of ECG repeated detection was more than 500ms. 4. Patients who underwent parathyroidectomy within 6 months before screening, or were likely to receive parathyroidectomy during the study period. 5. Diagnosis and / or treatment of malignant tumors (except skin basal cell carcinoma, cervical carcinoma in situ or prostate cancer in situ) in the past 5 years. 6. Active infection or antibiotic treatment within 2 weeks before screening. 7. History of HIV infection. 8. Receiving antiviral drugs for hepatitis B and / or hepatitis C within 4 weeks before screening. 9. Known active liver disease, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels are three times higher than the upper limit of normal. 10. Other drugs (prescription or over-the-counter) that have been accepted by the researcher within 2 weeks before screening or currently affecting the evaluation results of this study. 11. Receive any study drug within 4 weeks before screening. 12. Patients with life expectancy less than 12 months. 13. Patients who, for any reason, are considered unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| coronary artery calcification score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum phosphorus, calcium and parathyroid hormone levels;Serum lipoprotein a level;Serum fetuin A level;Cardiac function;The incidence of cardiovascular events;Quality of life; | — |
Countries
China
Contacts
Public ContactWei Zhou
Shanghai General Hospital
Outcome results
None listed