A Phase 4 interventional study of Lanthanum carbonate and Calcium Carbonate in Renal Insufficiency, Chronic, Hyperphosphatemia and Bone Diseases, Metabolic, sponsored by Osaka University. Status unknown at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by Osaka University · Phase 4, Interventional, and Treatment
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.
261 studies on the registry are indexed under Bone Diseases; 49 are open to participants now.
This study's planned enrollment of 60 is above the median of 54 across 148 interventional studies indexed under Bone Diseases.
Browse Bone Diseases studies →Osaka University is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Calcium Carbonate
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.
Drug: Lanthanum carbonate
Also known as: FOSRENOL®
Coronary artery calcification score
Time frame: 1 year
Endothelial function
Measured by EndoPAT™ (Itamar Medical Ltd.)
Time frame: 3 months
Serum bone metabolic markers
Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
Time frame: 3 months
Serum bone metabolic markers
Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
Time frame: 1 year
Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time
Time frame: Up to 1 year
Estimated glomerular filtration rate over time
Time frame: Up to 1 year
Bone mineral density
Time frame: 1 year
Serum osteoprotegerin concentration
Time frame: 3 month
Serum osteoprotegerin concentration
Time frame: 1 year
Urinary alpha-Klotho to creatinine ratio
Time frame: 3 months
Urinary alpha-Klotho to creatinine ratio
Time frame: 1 year
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
Time frame: 3 months
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
Time frame: 1 year
End-stage renal disease requiring renal replacement therapy
Time frame: Up to 1 year
Cardiovascular event requiring hospitalization
Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease
Time frame: Up to 1 year
Death
Time frame: Up to 1 year
Micro RNA array
Time frame: 1 year
Hypercalcemia
Corrected serum calcium concentration ≥11.0 mg/dL
Time frame: Up to 1 year
Hypocalcemia
Corrected serum calcium concentration \<8.5 mg/dL
Time frame: Up to 1 year
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Osaka University