Bone Diseases, Metabolic, Hyperphosphatemia, Renal Insufficiency, Chronic
Conditions
Keywords
Lanthanum, Calcium Carbonate, Vascular Calcification
Brief summary
The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.
Interventions
DRUGLanthanum carbonate
DRUGCalcium Carbonate
Sponsors
Bayer
Osaka University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL) * With written informed consent
Exclusion criteria
* History of cardiac surgery * With coronary artery stent * Polycystic kidney disease * Hypothyroidism * On treatment with lanthanum carbonate * History of admission within 3 months * History of ileus * Severe liver dysfunction * Severe gastrointestinal dysfunction * Allergy to lanthanum carbonate or calcium carbonate * Pregnant or breastfeeding women * Judged as ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coronary artery calcification score | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | Up to 1 year | — |
| Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio | 3 months | — |
| End-stage renal disease requiring renal replacement therapy | Up to 1 year | — |
| Cardiovascular event requiring hospitalization | Up to 1 year | Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease |
| Endothelial function | 3 months | Measured by EndoPAT™ (Itamar Medical Ltd.) |
| Serum bone metabolic markers | 3 months | Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b) |
| Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time | Up to 1 year | — |
| Estimated glomerular filtration rate over time | Up to 1 year | — |
| Bone mineral density | 1 year | — |
| Serum osteoprotegerin concentration | 3 month | — |
| Urinary alpha-Klotho to creatinine ratio | 3 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hypercalcemia | Up to 1 year | Corrected serum calcium concentration ≥11.0 mg/dL |
| Hypocalcemia | Up to 1 year | Corrected serum calcium concentration \<8.5 mg/dL |
| Micro RNA array | 1 year | — |
Countries
Japan
Outcome results
None listed