Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium carbonate | Active Comparator | Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 3,000 mg/day. |
|
| Lanthanum carbonate | Experimental | Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum carbonate | Drug |
|
| |
| Calcium Carbonate |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary artery calcification score | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | Measured by EndoPATâ„¢ (Itamar Medical Ltd.) | 3 months |
| Serum bone metabolic markers | Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b) |
| Measure | Description | Time Frame |
|---|---|---|
| Micro RNA array | 1 year | |
| Hypercalcemia | Corrected serum calcium concentration ≥11.0 mg/dL | Up to 1 year |
| Hypocalcemia |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Takayuki Hamano, MD, PhD | Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D054559 | Hyperphosphatemia |
| D001851 | Bone Diseases, Metabolic |
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| 3 months |
| Serum bone metabolic markers | Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b) | 1 year |
| 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 |
| Serum osteoprotegerin concentration | 1 year |
| Urinary alpha-Klotho to creatinine ratio | 3 months |
| Urinary alpha-Klotho to creatinine ratio | 1 year |
| Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio | 3 months |
| Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio | 1 year |
| End-stage renal disease requiring renal replacement therapy | Up to 1 year |
| Cardiovascular event requiring hospitalization | Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease | Up to 1 year |
| Death | Up to 1 year |
Corrected serum calcium concentration <8.5 mg/dL |
| Up to 1 year |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |