Coronary artery calcification in chronic renal failure patients undergoing hemodialysis
Conditions
Interventions
One-year treatment with sevelamer hydrochloride alone or combined use of sevelamer hydrochloride and calcium-based products
One-year treatment with calcium carbonate alone
Sponsors
Division of Nephrology and Metabolism, Department of Internal Medicine,Tokai University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 years or older and younger than 80 years at the time of consent 2. Patients with chronic renal failure undergoing maintenance hemodialysis three times a week at dialysis facilities 3. Patients in need of phosphate binders with serum phosphorus <6.5 mg/dL, corrected serum calcium <10.2 mg/dL, and intact-PTH between 150 and 300 pg/mL immediately before enrollment
Exclusion criteria
Exclusion criteria: 1. Patients who have received the test drugs within 12 weeks of enrollment 2. Patients who have undergone parathyroidectomy within one year of enrollment 3. Patients who have undergone parathyroid-targeted interventions (intra-parathyroid injection of ethanol, acetic acid, or vitamin D and its derivatives) within 24 weeks of enrollment 4. Patients who have received bisphosphonate products within 12 weeks of enrollment 5. Patients on estrogen replacement therapy 6. Patients receiving elcitonin 7. Patients receiving nicotinamide 8. Patients receiving sodium ferrous citrate (Proprietary name: Ferromia and others) 9. Patients receiving ipriflavone (Proprietary name: Osten and others) 10. Patients receiving vitamin K2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group-to-group comparisons of the changes in coronary artery calcification score and blood parameters including plasma pentosidine concentration occurring during one year of test drug administration from enrollment | — |
Countries
Japan
Outcome results
None listed