chronic kidney disease patients with hyperparathyroidism undergoing hemodialysis
Conditions
Interventions
None listed
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: (Exclusion criteria that would otherwise affect outcomes) 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 (Proprietary name: Glakay and others) (Exclusion criteria in consideration of safety) 1. Patients with severe gastrointestinal conditions 2. Patients infected with HIV 3. Patients with vasculitis or vascular disorders 4. Patients complicated with severe hepatic dysfunction or cirrhosis 5. Patients complicated with severe cardiac conditions (New York Heart Association Classification, Class III or higher) 6. Patients with uncontrollable diabetes 7. Patients with HbA1c 9% or higher 8. Patients with uncontrollable hypertension 9. Patients unfit for dialysis 10. Patients who are likely prone to severe drug allergy such as anaphylactic shock or who have past or current history of drug or alcohol intoxication 11. Women who are pregnant, lactating or suspected of pregnancy 12. Patients with serious complications such as malignancy and serious infections 13. Patients with any one of the contraindications indicated on the package insert of lanthanum carbonate 14. Patients who are judged unfit as subjects of the study by investigators, sub-investigators or collaborators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparisons of the changes in PTGs` size , coronary artery calcification score and blood parameters concentration occurring during one year of test drug administration from enrollment | — |
Countries
Japan
Contacts
Public ContactTakatoshi Kakuta
Tokai University School of Medicine Division of Nephrology and Metabolism, Department of Internal Medicine
Outcome results
None listed