chronic kidney disease
Conditions
Interventions
The period of treatment of patients randomized to active form of vitamin D group is 52 weeks. The initial dose of active form of vitamin D, which is alphacalcidol, is 0.25 microgram/day or 0.5 micro
=8.5 mg/dl and <
10.0 mg/dl.
The period of treatment of patients randomized to combination of active form of vitamin D and lanthanum carbonate group is 52 weeks. The initial dose of active form of vitamin D, which i
10.0 mg/dl. In addition, investigators control dose of lanthanum carbonate to set serum phosphate level to >
=3.5 mg/dl and <
6.0 mg/dl.
Sponsors
Fujita Health University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We include patients who meet conditions below: 1. eGFR is >=10 and < 45 ml/min/1.73m2 2. serum corrected calcium level is less than 9.5 mg/dL 3. serum phosphate level is >=4 and < 6 mg/dL 4. serum intact PTH level is >=60 pg/mL
Exclusion criteria
Exclusion criteria: We exclude patients who meet conditions below: 1. patients who have taken active form of vitamin D within 4 weeks. 2. patients who have taken any supplements including natural form of vitamin D within 4 weeks. 3. patients who have taken any phosphate binders within 4 weeks. 4. patients who do not agree with the study 5. patients whom one or more investigators do not regard as appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of serum FGF23 level after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| changes of laboratory data including other bone metabolic markers, results of echocardiogram, changes of aortic calcification score, amounts of active form of vitamin D or lanthanum carbonate | — |
Countries
Japan
Contacts
Public ContactDaijo Inaguma
Fujita Health University Department of Nephrology
Outcome results
None listed